fda-mcp-server 0.0.3 → 0.0.7

package/dist/db.d.ts

@@ -101,5 +101,23 @@ export interface SupplierQualResult {
     }[];
     csa_risk: CSARiskResult | null;
 }
+export interface CompanyEnrichedResult {
+    warning_letters: {
+        issue_date: string;
+        center: string;
+        regime: string;
+        csa_relevant: boolean;
+        subject: string;
+    }[];
+    inspections: {
+        inspection_date: string;
+        center: string;
+        product_area: string;
+        csa_relevant: boolean;
+    }[];
+    total_warning_letters: number;
+    total_inspections: number;
+}
+export declare function companyEnrichedProfile(companyName: string): Promise<CompanyEnrichedResult | null>;
 export declare function supplierQualification(companyName: string): Promise<SupplierQualResult | null>;
 //# sourceMappingURL=db.d.ts.map

package/dist/db.d.ts.map

@@ -1 +1 @@
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+{"version":3,"file":"db.d.ts","sourceRoot":"","sources":["../src/db.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;;;;GAcG;AAEH,OAAO,EAAE,MAAM,IAAI,CAAC;AAKpB,wBAAgB,OAAO,IAAI,EAAE,CAAC,IAAI,GAAG,IAAI,CAkBxC;AAED,wBAAgB,mBAAmB,IAAI,OAAO,CAE7C;AAED;;;;GAIG;AACH,wBAAgB,cAAc,IAAI;IAAE,KAAK,EAAE,OAAO,CAAC;IAAC,OAAO,CAAC,EAAE,MAAM,CAAA;CAAE,CAqBrE;AAED,wBAAsB,cAAc,IAAI,OAAO,CAAC,OAAO,CAAC,CASvD;AAID,MAAM,WAAW,aAAa;IAC5B,YAAY,EAAE,MAAM,CAAC;IACrB,oBAAoB,EAAE,MAAM,CAAC;IAC7B,wBAAwB,EAAE,MAAM,CAAC;IACjC,eAAe,EAAE,MAAM,CAAC;IACxB,aAAa,EAAE,MAAM,CAAC;IACtB,gBAAgB,EAAE,MAAM,CAAC;IACzB,oBAAoB,EAAE,MAAM,CAAC;IAC7B,aAAa,EAAE,MAAM,EAAE,CAAC;IACxB,iBAAiB,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC3E,UAAU,EAAE,MAAM,CAAC;IACnB,UAAU,EAAE,KAAK,GAAG,UAAU,GAAG,MAAM,GAAG,UAAU,CAAC;IACrD,qBAAqB,EAAE,MAAM,CAAC;CAC/B;AAED,wBAAsB,iBAAiB,CACrC,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,aAAa,GAAG,IAAI,CAAC,CAoG/B;AAED,MAAM,WAAW,sBAAsB;IACrC,eAAe,EAAE,MAAM,CAAC;IACxB,OAAO,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC3C,WAAW,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC/C,WAAW,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAC;QAAC,YAAY,EAAE,OAAO,CAAA;KAAE,EAAE,CAAC;IAC1E,YAAY,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,WAAW,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IACzE,cAAc,EAAE,MAAM,CAAC;CACxB;AAED,wBAAsB,gBAAgB,CAAC,MAAM,EAAE;IAC7C,QAAQ,CAAC,EAAE,MAAM,CAAC;IAClB,QAAQ,CAAC,EAAE,MAAM,CAAC;IAClB,MAAM,CAAC,EAAE,MAAM,CAAC;IAChB,WAAW,CAAC,EAAE,MAAM,CAAC;CACtB,GAAG,OAAO,CAAC,sBAAsB,GAAG,IAAI,CAAC,CAqFzC;AAED,MAAM,WAAW,kBAAkB;IACjC,YAAY,EAAE,MAAM,CAAC;IACrB,WAAW,EAAE,MAAM,EAAE,CAAC;IACtB,eAAe,EAAE;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,MAAM,EAAE,MAAM,CAAC;QACf,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,OAAO,CAAC;QACtB,GAAG,EAAE,MAAM,CAAC;KACb,EAAE,CAAC;IACJ,WAAW,EAAE;QACX,mBAAmB,EAAE,MAAM,CAAC;QAC5B,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,MAAM,CAAC;QACrB,YAAY,EAAE,OAAO,CAAC;KACvB,EAAE,CAAC;IACJ,gBAAgB,EAAE;QAAE,QAAQ,EAAE,MAAM,CAAC;QAAC,QAAQ,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IAC1E,aAAa,EAAE;QAAE,IAAI,EAAE,MAAM,CAAC;QAAC,UAAU,EAAE,MAAM,CAAC;QAAC,KAAK,EAAE,MAAM,CAAA;KAAE,EAAE,CAAC;IACrE,QAAQ,EAAE,aAAa,GAAG,IAAI,CAAC;CAChC;AAED,MAAM,WAAW,qBAAqB;IACpC,eAAe,EAAE;QACf,UAAU,EAAE,MAAM,CAAC;QACnB,MAAM,EAAE,MAAM,CAAC;QACf,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,OAAO,CAAC;QACtB,OAAO,EAAE,MAAM,CAAC;KACjB,EAAE,CAAC;IACJ,WAAW,EAAE;QACX,eAAe,EAAE,MAAM,CAAC;QACxB,MAAM,EAAE,MAAM,CAAC;QACf,YAAY,EAAE,MAAM,CAAC;QACrB,YAAY,EAAE,OAAO,CAAC;KACvB,EAAE,CAAC;IACJ,qBAAqB,EAAE,MAAM,CAAC;IAC9B,iBAAiB,EAAE,MAAM,CAAC;CAC3B;AAED,wBAAsB,sBAAsB,CAC1C,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,qBAAqB,GAAG,IAAI,CAAC,CAyDvC;AAED,wBAAsB,qBAAqB,CACzC,WAAW,EAAE,MAAM,GAClB,OAAO,CAAC,kBAAkB,GAAG,IAAI,CAAC,CAgGpC"}

package/dist/db.js

@@ -93,7 +93,7 @@ export async function csaRiskAssessment(companyName) {
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
     // Top CFR citations
-    const topCfr = await p.query(`SELECT c.cfr_full, c.normalized_category, COUNT(*) AS cnt
+    const topCfr = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category, COUNT(*) AS cnt
      FROM citation c
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)
@@ -180,7 +180,7 @@ export async function citationAnalysis(params) {
     const byType = await p.query(`SELECT c.citation_type AS type, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.citation_type ORDER BY cnt DESC`, values);
-    const byPart = await p.query(`SELECT c.cfr_part AS part, COUNT(*) AS cnt
+    const byPart = await p.query(`SELECT COALESCE(c.cfr_part::text, 'N/A') AS part, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.cfr_part ORDER BY cnt DESC LIMIT 15`, values);
     const byCategory = await p.query(`SELECT c.normalized_category AS category, COUNT(*) AS cnt,
@@ -190,7 +190,7 @@ export async function citationAnalysis(params) {
        ) THEN true ELSE false END AS csa_relevant
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.normalized_category ORDER BY cnt DESC`, values);
-    const topSections = await p.query(`SELECT c.cfr_full, c.normalized_category AS description, COUNT(*) AS cnt
+    const topSections = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category AS description, COUNT(*) AS cnt
      FROM citation c JOIN warning_letter wl ON c.letter_id = wl.id ${where}
      GROUP BY c.cfr_full, c.normalized_category ORDER BY cnt DESC LIMIT 20`, values);
     const total = parseInt(totalResult.rows[0]?.total ?? "0");
@@ -214,6 +214,48 @@ export async function citationAnalysis(params) {
         csa_percentage: total > 0 ? Math.round((csaCount / total) * 100 * 10) / 10 : 0,
     };
 }
+export async function companyEnrichedProfile(companyName) {
+    const p = getPool();
+    if (!p)
+        return null;
+    const wlResult = await p.query(`SELECT
+       to_char(to_timestamp(issue_date), 'YYYY-MM-DD') AS issue_date,
+       center, regime, csa_relevant,
+       COALESCE(letter_subject, '') AS subject
+     FROM warning_letter
+     WHERE LOWER(company_name) LIKE LOWER($1)
+     ORDER BY issue_date DESC
+     LIMIT 10`, [`%${companyName}%`]);
+    const wlCount = await p.query(`SELECT COUNT(*) AS cnt FROM warning_letter WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
+    const inspResult = await p.query(`SELECT
+       CASE WHEN inspection_end_date IS NOT NULL
+         THEN to_char(to_timestamp(inspection_end_date), 'YYYY-MM-DD')
+         ELSE ''
+       END AS inspection_date,
+       center, product_area, csa_relevant
+     FROM observation_483
+     WHERE LOWER(company_name) LIKE LOWER($1)
+     ORDER BY inspection_end_date DESC
+     LIMIT 10`, [`%${companyName}%`]);
+    const inspCount = await p.query(`SELECT COUNT(*) AS cnt FROM observation_483 WHERE LOWER(company_name) LIKE LOWER($1)`, [`%${companyName}%`]);
+    return {
+        warning_letters: wlResult.rows.map((r) => ({
+            issue_date: r.issue_date ?? "",
+            center: r.center ?? "",
+            regime: r.regime ?? "",
+            csa_relevant: r.csa_relevant ?? false,
+            subject: r.subject ?? "",
+        })),
+        inspections: inspResult.rows.map((r) => ({
+            inspection_date: r.inspection_date ?? "",
+            center: r.center ?? "",
+            product_area: r.product_area ?? "",
+            csa_relevant: r.csa_relevant ?? false,
+        })),
+        total_warning_letters: parseInt(wlCount.rows[0]?.cnt ?? "0"),
+        total_inspections: parseInt(inspCount.rows[0]?.cnt ?? "0"),
+    };
+}
 export async function supplierQualification(companyName) {
     const p = getPool();
     if (!p)
@@ -232,14 +274,19 @@ export async function supplierQualification(companyName) {
      WHERE LOWER(company_name) LIKE LOWER($1)
      ORDER BY issue_date DESC
      LIMIT 20`, [`%${companyName}%`]);
-    // 483 inspections
-    const inspResult = await p.query(`SELECT inspection_end_date, center, product_area, csa_relevant
+    // 483 inspections (inspection_end_date is stored as Unix epoch)
+    const inspResult = await p.query(`SELECT
+       CASE WHEN inspection_end_date IS NOT NULL
+         THEN to_char(to_timestamp(inspection_end_date), 'YYYY-MM-DD')
+         ELSE ''
+       END AS inspection_date,
+       center, product_area, csa_relevant
      FROM observation_483
      WHERE LOWER(company_name) LIKE LOWER($1)
      ORDER BY inspection_end_date DESC
      LIMIT 20`, [`%${companyName}%`]);
     // Citation summary
-    const citResult = await p.query(`SELECT c.cfr_full, c.normalized_category, COUNT(*) AS cnt
+    const citResult = await p.query(`SELECT COALESCE(c.cfr_full, 'N/A') AS cfr_full, c.normalized_category, COUNT(*) AS cnt
      FROM citation c
      JOIN warning_letter wl ON c.letter_id = wl.id
      WHERE LOWER(wl.company_name) LIKE LOWER($1)
@@ -267,7 +314,7 @@ export async function supplierQualification(companyName) {
             url: r.url ?? "",
         })),
         inspections: inspResult.rows.map((r) => ({
-            inspection_end_date: r.inspection_end_date ?? "",
+            inspection_end_date: r.inspection_date ?? "",
             center: r.center ?? "",
             product_area: r.product_area ?? "",
             csa_relevant: r.csa_relevant ?? false,

package/dist/db.js.map

@@ -1 +1 @@
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package/dist/fda-client.d.ts

@@ -1,22 +1,10 @@
 /**
- * FDA API Client
+ * openFDA API Client
  *
- * Wraps FDA public data sources:
- * 1. FDA.gov Warning Letters (Drupal DataTables / Solr)
- * 2. FDA.gov 483 Inspection Observations (FOIA Reading Room)
- * 3. openFDA Enforcement/Recalls API
+ * Wraps public openFDA data sources:
+ * 1. Enforcement/Recalls (drug, device, food)
+ * 2. Device Adverse Events (MAUDE database)
  */
-export interface WarningLetter {
-    posted_date: string;
-    issue_date: string;
-    company_name: string;
-    issuing_office: string;
-    subject: string;
-    response_letter: string;
-    closeout_letter: string;
-    excerpt: string;
-    url: string;
-}
 export interface EnforcementRecord {
     recall_number: string;
     status: string;
@@ -37,58 +25,45 @@ export interface EnforcementRecord {
     termination_date: string;
     event_id: string;
 }
-export interface InspectionRecord {
-    firm_name: string;
-    fei_number: string;
-    city: string;
-    state: string;
-    country: string;
-    zip_code: string;
-    inspection_end_date: string;
-    classification: string;
-    center: string;
-    project_area: string;
-    posted_citations: string;
-    url?: string;
+export interface DeviceEventRecord {
+    report_number: string;
+    event_type: string;
+    date_received: string;
+    date_of_event: string;
+    device_name: string;
+    manufacturer: string;
+    brand_name: string;
+    product_code: string;
+    event_description: string;
+    patient_outcome: string[];
+    device_class: string;
 }
-export declare function searchWarningLetters(params: {
+export declare function searchEnforcement(params: {
     search?: string;
-    issuing_office?: string;
-    limit?: number;
-    offset?: number;
-    date_from?: string;
-    date_to?: string;
-}): Promise<{
-    total: number;
-    letters: WarningLetter[];
-}>;
-export declare function get483XlsxUrls(): Record<string, string>;
-export declare function searchInspections(params: {
-    firm_name?: string;
+    product_type?: "drug" | "device" | "food";
+    classification?: "Class I" | "Class II" | "Class III";
     state?: string;
-    center?: string;
-    project_area?: string;
-    limit?: number;
-    offset?: number;
+    recalling_firm?: string;
     date_from?: string;
     date_to?: string;
+    limit?: number;
+    skip?: number;
 }): Promise<{
     total: number;
-    inspections: InspectionRecord[];
-    note?: string;
+    records: EnforcementRecord[];
 }>;
-export declare function searchEnforcement(params: {
+export declare function searchDeviceEvents(params: {
     search?: string;
-    product_type?: "drug" | "device" | "food";
-    classification?: "Class I" | "Class II" | "Class III";
-    state?: string;
-    recalling_firm?: string;
+    manufacturer?: string;
+    brand_name?: string;
+    event_type?: "Injury" | "Malfunction" | "Death" | "Other";
+    product_code?: string;
     date_from?: string;
     date_to?: string;
     limit?: number;
     skip?: number;
 }): Promise<{
     total: number;
-    records: EnforcementRecord[];
+    events: DeviceEventRecord[];
 }>;
 //# sourceMappingURL=fda-client.d.ts.map

package/dist/fda-client.d.ts.map

@@ -1 +1 @@
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package/dist/fda-client.js

@@ -1,135 +1,16 @@
 /**
- * FDA API Client
+ * openFDA API Client
  *
- * Wraps FDA public data sources:
- * 1. FDA.gov Warning Letters (Drupal DataTables / Solr)
- * 2. FDA.gov 483 Inspection Observations (FOIA Reading Room)
- * 3. openFDA Enforcement/Recalls API
+ * Wraps public openFDA data sources:
+ * 1. Enforcement/Recalls (drug, device, food)
+ * 2. Device Adverse Events (MAUDE database)
  */
-const FDA_BASE = "https://www.fda.gov";
 const OPENFDA_BASE = "https://api.fda.gov";
-// ─── Warning Letters (FDA.gov DataTables) ────────────────────────────────────
-export async function searchWarningLetters(params) {
-    const userLimit = Math.min(params.limit ?? 25, 100);
-    const offset = params.offset ?? 0;
-    const hasPostFilters = !!(params.search || params.issuing_office || params.date_from || params.date_to);
-    // FDA.gov DataTables/Solr endpoint does NOT support server-side filtering.
-    // search[value] only influences Solr relevance ranking (floats matches to top).
-    // All filtering (company name, issuing_office, dates) must happen client-side.
-    // When any filter is active, fetch max 100 rows to maximize the filterable pool.
-    const fetchLimit = hasPostFilters ? 100 : userLimit;
-    const url = new URL("/datatables/views/ajax", FDA_BASE);
-    url.searchParams.set("view_name", "warning_letter_solr_index");
-    url.searchParams.set("view_display_id", "warning_letter_solr_block");
-    url.searchParams.set("view_base_path", "inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters/datatables-data");
-    url.searchParams.set("draw", "1");
-    url.searchParams.set("start", String(offset));
-    url.searchParams.set("length", String(fetchLimit));
-    // Use search[value] for Solr relevance ranking — not a filter, but floats matches up
-    if (params.search) {
-        url.searchParams.set("search[value]", params.search);
-    }
-    const resp = await fetch(url.toString(), {
-        headers: {
-            Accept: "application/json",
-            "User-Agent": "fda-mcp-server/1.0",
-        },
-    });
-    if (!resp.ok) {
-        throw new Error(`FDA Warning Letters API returned ${resp.status}: ${resp.statusText}`);
-    }
-    const data = await resp.json();
-    const records = (data.data ?? []).map((row) => parseWarningLetterRow(row));
-    // Client-side filtering — the only filtering that actually works on this endpoint
-    let filtered = records;
-    if (params.search) {
-        const searchTerm = params.search.toLowerCase();
-        filtered = filtered.filter((r) => r.company_name.toLowerCase().includes(searchTerm) ||
-            r.subject.toLowerCase().includes(searchTerm) ||
-            r.excerpt.toLowerCase().includes(searchTerm));
-    }
-    if (params.issuing_office) {
-        const office = params.issuing_office.toLowerCase();
-        filtered = filtered.filter((r) => r.issuing_office.toLowerCase().includes(office));
-    }
-    if (params.date_from || params.date_to) {
-        filtered = filtered.filter((r) => {
-            const d = r.issue_date;
-            if (params.date_from && d < params.date_from)
-                return false;
-            if (params.date_to && d > params.date_to)
-                return false;
-            return true;
-        });
-    }
-    // Trim to user-requested limit after filtering
-    const result = filtered.slice(0, userLimit);
-    return {
-        // Always report the actual filtered count, never the server's misleading recordsTotal
-        total: hasPostFilters ? filtered.length : (data.recordsFiltered ?? data.recordsTotal ?? records.length),
-        letters: result,
-    };
-}
-function parseWarningLetterRow(row) {
-    // DataTables rows come as arrays or objects depending on config
-    if (Array.isArray(row)) {
-        return {
-            posted_date: stripHtml(row[0] ?? ""),
-            issue_date: stripHtml(row[1] ?? ""),
-            company_name: stripHtml(row[2] ?? ""),
-            issuing_office: stripHtml(row[3] ?? ""),
-            subject: stripHtml(row[4] ?? ""),
-            response_letter: stripHtml(row[5] ?? ""),
-            closeout_letter: stripHtml(row[6] ?? ""),
-            excerpt: stripHtml(row[7] ?? ""),
-            url: extractHref(row[2] ?? "") || extractHref(row[4] ?? ""),
-        };
-    }
-    // Object format
-    return {
-        posted_date: stripHtml(row.field_letter_posted_date ?? row.posted_date ?? ""),
-        issue_date: stripHtml(row.field_letter_issue_datetime ?? row.issue_date ?? ""),
-        company_name: stripHtml(row.field_company_name_warning_lette ?? row.company_name ?? ""),
-        issuing_office: stripHtml(row.field_issuing_office ?? row.issuing_office ?? ""),
-        subject: stripHtml(row.field_subject ?? row.subject ?? ""),
-        response_letter: stripHtml(row.field_response_letter_date ?? row.response_letter ?? ""),
-        closeout_letter: stripHtml(row.field_closeout_letter_date ?? row.closeout_letter ?? ""),
-        excerpt: stripHtml(row.field_letter_body ?? row.excerpt ?? ""),
-        url: extractHref(row.field_company_name_warning_lette ?? row.field_subject ?? ""),
-    };
-}
-// ─── 483 Inspections ─────────────────────────────────────────────────────────
-//
-// FDA removed the DataTables AJAX endpoint for 483 observations. The page now
-// only offers annual XLSX downloads (FY2006–FY2025). Live search is not
-// possible. This function queries the enriched fda-csa-data PostgreSQL dataset
-// when DATABASE_URL is set, or returns a helpful message pointing to XLSX
-// downloads and the enriched dataset.
-const FDA_483_XLSX_URLS = {
-    "2025": "https://www.fda.gov/media/190190/download?attachment",
-    "2024": "https://www.fda.gov/media/185090/download?attachment",
-    "2023": "https://www.fda.gov/media/174101/download?attachment",
-    "2022": "https://www.fda.gov/media/163420/download?attachment",
-    "2021": "https://www.fda.gov/media/153238/download?attachment",
-};
-export function get483XlsxUrls() {
-    return FDA_483_XLSX_URLS;
-}
-export async function searchInspections(params) {
-    // FDA removed the live DataTables endpoint — no live search available.
-    // Return empty with an explanation so the tool handler can provide guidance.
-    return {
-        total: 0,
-        inspections: [],
-        note: "FDA removed the live 483 inspection search endpoint. 483 observation data is now only available as annual XLSX downloads from FDA.gov, or via the enriched fda-csa-data dataset (use csa_risk_assessment or supplier_qualification_report tools for 483 data).",
-    };
-}
 // ─── openFDA Enforcement (Recalls) ───────────────────────────────────────────
 export async function searchEnforcement(params) {
     const product = params.product_type ?? "drug";
     const limit = Math.min(params.limit ?? 25, 100);
     const skip = params.skip ?? 0;
-    // Build openFDA search query
     const searchParts = [];
     if (params.search) {
         searchParts.push(`"${params.search}"`);
@@ -155,17 +36,14 @@ export async function searchEnforcement(params) {
     url.searchParams.set("limit", String(limit));
     url.searchParams.set("skip", String(skip));
     const resp = await fetch(url.toString(), {
-        headers: {
-            "User-Agent": "fda-mcp-server/1.0",
-        },
+        headers: { "User-Agent": "fda-mcp-server/1.0" },
     });
     if (!resp.ok) {
-        if (resp.status === 404) {
+        if (resp.status === 404)
             return { total: 0, records: [] };
-        }
         throw new Error(`openFDA enforcement API returned ${resp.status}: ${resp.statusText}`);
     }
-    const data = await resp.json();
+    const data = (await resp.json());
     const records = (data.results ?? []).map((r) => ({
         recall_number: r.recall_number ?? "",
         status: r.status ?? "",
@@ -191,25 +69,72 @@ export async function searchEnforcement(params) {
         records,
     };
 }
-// ─── Utilities ───────────────────────────────────────────────────────────────
-function stripHtml(s) {
-    return s
-        .replace(/<[^>]*>/g, "")
-        .replace(/&amp;/g, "&")
-        .replace(/&lt;/g, "<")
-        .replace(/&gt;/g, ">")
-        .replace(/&quot;/g, '"')
-        .replace(/&#039;/g, "'")
-        .replace(/&nbsp;/g, " ")
-        .trim();
-}
-function extractHref(s) {
-    const match = s.match(/href="([^"]+)"/);
-    if (!match)
-        return "";
-    const href = match[1];
-    if (href.startsWith("http"))
-        return href;
-    return `${FDA_BASE}${href.startsWith("/") ? "" : "/"}${href}`;
+// ─── openFDA Device Adverse Events (MAUDE) ───────────────────────────────────
+export async function searchDeviceEvents(params) {
+    const limit = Math.min(params.limit ?? 25, 100);
+    const skip = params.skip ?? 0;
+    const searchParts = [];
+    if (params.search) {
+        searchParts.push(`"${params.search}"`);
+    }
+    if (params.manufacturer) {
+        searchParts.push(`device.manufacturer_d_name:"${params.manufacturer}"`);
+    }
+    if (params.brand_name) {
+        searchParts.push(`device.brand_name:"${params.brand_name}"`);
+    }
+    if (params.event_type) {
+        searchParts.push(`event_type:"${params.event_type}"`);
+    }
+    if (params.product_code) {
+        searchParts.push(`device.generic_name:"${params.product_code}"`);
+    }
+    if (params.date_from || params.date_to) {
+        const from = params.date_from?.replace(/-/g, "") ?? "19000101";
+        const to = params.date_to?.replace(/-/g, "") ?? "20991231";
+        searchParts.push(`date_received:[${from}+TO+${to}]`);
+    }
+    const url = new URL("/device/event.json", OPENFDA_BASE);
+    if (searchParts.length > 0) {
+        url.searchParams.set("search", searchParts.join("+AND+"));
+    }
+    url.searchParams.set("limit", String(limit));
+    url.searchParams.set("skip", String(skip));
+    const resp = await fetch(url.toString(), {
+        headers: { "User-Agent": "fda-mcp-server/1.0" },
+    });
+    if (!resp.ok) {
+        if (resp.status === 404)
+            return { total: 0, events: [] };
+        throw new Error(`openFDA device events API returned ${resp.status}: ${resp.statusText}`);
+    }
+    const data = (await resp.json());
+    const events = (data.results ?? []).map((r) => {
+        const device = r.device?.[0] ?? {};
+        const description = (r.mdr_text ?? [])
+            .map((t) => t.text ?? "")
+            .filter(Boolean)
+            .join(" ")
+            .substring(0, 500) || "";
+        return {
+            report_number: r.report_number ?? "",
+            event_type: r.event_type ?? "",
+            date_received: r.date_received ?? "",
+            date_of_event: r.date_of_event ?? "",
+            device_name: device.generic_name ?? "",
+            manufacturer: device.manufacturer_d_name ?? "",
+            brand_name: device.brand_name ?? "",
+            product_code: device.device_report_product_code ?? "",
+            event_description: description,
+            patient_outcome: r.patient?.[0]?.patient_sequence_number
+                ? (r.patient ?? []).map((p) => p.sequence_number_outcome?.[0] ?? "").filter(Boolean)
+                : [],
+            device_class: device.device_class ?? "",
+        };
+    });
+    return {
+        total: data.meta?.results?.total ?? events.length,
+        events,
+    };
 }
 //# sourceMappingURL=fda-client.js.map

package/dist/fda-client.js.map

@@ -1 +1 @@
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