BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 23566314 · Received November 17, 2025

    Report

    Report Number
    1000317571-2025-00136
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Report Date
    October 23, 2025
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. COMPLAINT: FOREIGN MATTER (E.G. HAIRS, INSECTS) WITHIN PRIMARY PACK (STERILE PRODUCTS). REGION: SWITZERLAND. PRODUCT / SYSTEM APPLICATION PRODUCT (SAP): 1730133 ¿ AQUACEL FOAM ADH 10X10CM (1X10PK) STER DE. LOT: 4J03899. DATE OF MANUFACTURE: 21 SEP 2024. STERILIZATION: STERIGENICS WO: (B)(4) ON (B)(6) 2025. COMPLAINT WAS RECEIVED FROM SWITZERLAND REPORTING FOREIGN MATTER (HAIR) IN A PRIMARY PACK OF AQUACEL FOAM ADH 10X10CM (1X10PK) STER DE, MATERIAL: 1730133, BATCH: 4J03899. THE LOT WAS MANUFACTURED ON 21 SEP 2024 AND STERILIZED UNDER STERIGENICS CERTIFICATE WO: (B)(4) ON (B)(6) 2025. BATCH SIZE: 10368 SECONDARY PACKS (103680 PRIMARY). COMPLAINT STATES: DURING THE TRADE FAIR IN LUCERNE, WE NOTICED THE MARK ON THE PRODUCT SURFACE FROM A PRODUCT SAMPLE. THE PACKAGING HAS NOT BEEN OPENED. TWO PHOTOGRAPHS PROVIDED AND CONFIRM THE HAIR CONTAMINATION IN PRIMARY PACK. NO PHYSICAL SAMPLE WAS RECEIVED. THE COMPLAINT IS CONFIRMED FROM THE PHOTOGRAPHIC EVIDENCE PROVIDED. A BATCH RECORD REVIEW WAS COMPLETED FOR LOT: 4J03899. ALL IN-PROCESS CHECKS, QUALITY CONTROL (QC) CHECKS, AND FINAL RELEASE INSPECTIONS WERE DOCUMENTED AS ACCEPTABLE. NO DEVIATIONS, REWORK, OR NONCONFORMANCE'S WERE RECORDED. NO LABEL OR PACKAGING EQUIPMENT ISSUES WERE NOTED. GOOD MANUFACTURING PRACTICE (GMP) COMPLIANCE RECORDS CONFIRM THAT ENVIRONMENTAL AND GOWNING PROCEDURES WERE IN PLACE AND VERIFIED FOR THE PRODUCTION PERIOD. NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT, AND NO SIMILAR ISSUES HAVE BEEN REPORTED FOR THIS PRODUCT IN OTHER LOTS. ZERO IN THE LAST 12 MONTHS FOR MATERIAL CODE 1704025 ¿ NO OTHER COMPLAINTS FOR THIS PRODUCT CODE 3 OTHER COMPLAINTS FOR HAIR IN DRESSING HAVE BEEN RAISED IN 12 MONTHS MATERIAL: 1713678, BATCH: 3L03835 CONVATEC FOAM LITE 8X8CM 1X10 STER EC ¿ PRODUCT MADE ON CIRCLE LINE IMPACTING ONE DRESSING. MATERIAL: 1727476, BATCH: 4L03650- AQ FOAM PRO HEEL19.8X14CM 1X10 STER EUR PRODUCT WAS MADE ON THE OPTIMA LINE WITH ONLY ONE DRESSING IMPACTED. MATERIAL: 1724192, BATCH: 4M03618 - AQUACEL FOAM PRO 15X15 1X10PK NAI. PRODUCT MADE ON CIRCLE LINE IMPACTING ONE DRESSING. ALTHOUGH THREE PREVIOUS COMPLAINTS HAVE BEEN CODED AS FOREIGN MATTER (E.G. HAIRS INSECTS) WITHIN PRIMARY PACK (STERILE PRODUCTS) WITHIN THE LAST 12 MONTHS, THEY OCCURRED ON DIFFERENT PRODUCT CODES AND DIFFERENT MANUFACTURING LOTS: (3L03835, 4L03650, 4M03618). THE CURRENT COMPLAINT IS THE ONLY COMPLAINT ASSOCIATED WITH ITS SPECIFIC LOT. AS HOT BATCH CRITERIA REQUIRE MULTIPLE COMPLAINTS OF THE SAME MALFUNCTION AND THE SAME LOT, THE CRITERIA HAVE NOT BEEN MET. THIS COMPLAINT IS NOT A HOT BATCH AND IS CORRECTLY MANAGED AS A TYPE 2 INVESTIGATION. HISTORICAL INVESTIGATIONS CONFIRMED THAT WHILE CURRENT PERSONAL PROTECTIVE EQUIPMENT'S (PPES) IS COMPLIANT FOR CONTROLLED ENVIRONMENT USE, IT MAY STILL ALLOW OCCASIONAL LOOSE HAIRS TO TRANSFER FROM GARMENTS OR OPERATOR HANDLING. SUPPLIER MATERIAL TRANSFER CANNOT BE ENTIRELY RULED OUT. GOOD MANUFACTURING PRACTICE (GMP) AUDITS ARE PERFORMED REGULARLY TO VERIFY COMPLIANCE WITH GOWNING AND ENVIRONMENTAL CONTROL'S. THE ACCEPTABLE QUALITY LEVEL (AQL) FOR CONTAMINATION PER PROCEDURE (PD) IS ACCEPT AT 3 REJECT AT 4 WITH 315 SAMPLES. TOTAL STOCK EXSUARSTED FROM DCS ¿ NO OTHER COMPLAINTS RECEIVED ¿ THEREFORE NO EXCURSION OF ACCEPTABLE QUALITY LEVEL (AQL). AT MANUFACTURE, LOT: 4J03899 MET INSPECTION ACCEPTANCE CRITERIA. POST-DISTRIBUTION, ONE AFFECTED UNIT HAVE BEEN REPORTED FROM 10368 DISTRIBUTED UNITS. THIS EQUATES TO A RATE BELOW THE 0.40 ACCEPTABLE QUALITY LEVEL (AQL) THRESHOLD ACROSS THE FULL BATCH SIZE AND DOES NOT CONSTITUTE AN ACCEPTABLE QUALITY LEVEL (AQL) EXCURSION. ROOT-CAUSE ANALYSIS: THE PRESENCE OF THE HAIR WITHIN THE DRESSING WOULD NOT HAVE BEEN DETECTABLE TO OPERATORS DURING THE STANDARD ONLINE MANUAL INSPECTIONS. DUE TO THE LINE SPEED, OPERATORS FOCUS ON THE VISIBLE SURFACES OF THE DRESSING AND PACKAGING AS IT PASSES THROUGH THE INSPECTION ZONE. IN THIS CASE, THE HAIR BECAME TRAPPED ON THE WEB PATH PRIOR TO THE FINAL SEALING PROCESS. ONCE THE TOP FILM WAS APPLIED AND SEALED, THE CONTAMINATION WAS NO LONGER VISIBLE EXTERNALLY, MEANING IT COULD NOT BE IDENTIFIED DURING ROUTINE IN-PROCESS VISUAL CHECKS. AS A RESULT, THE CONTAMINATION REMAINED CONCEALED WITHIN THE SEALED SACHET AND WAS ONLY OBSERVABLE UPON OPENING BY THE END USER. WITH ONLY TWO UNITS AFFECTED, THE BATCH REMAINS WITHIN SPECIFICATION AND ACCEPTABLE QUALITY LIMITS. THE ISSUE IS CONSIDERED ISOLATED, WITH NO SYSTEMIC RECURRENCE IDENTIFIED. NO CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) IS REQUIRED. THE COMPLAINT WILL BE MONITORED THROUGH ROUTINE TRENDING AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

    THE COMPANY EMPLOYEE COMPLAINED REGARDING THE MARK ON THE SURFACE OF THE DRESSING (HAIR) THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281954 AQUACEL FOAM DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420680 4J03899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown