BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 17570568 · Received August 18, 2023

    Report

    Report Number
    1000317571-2023-00178
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 24, 2023
    Report Date
    July 24, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455129089
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT CITY: (B)(6). COMPLAINANT POSTAL CODE: (B)(6). COMPLAINANT COUNTRY: FRANCE. NAME OF AFFILIATION: OXYPHARM. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. ALL IN-PROCESS STAT SAMPLE QUALITY CHECKS WERE SATISFACTORY. AQUACEL FOAM ADH 8X8CM 1X10 EUR WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1707743 AND MANUFACTURING LOT NUMBER 3B00195 ON 06 FEB 2023. LOT # 3B00195 WAS STERILIZED UNDER WORK ORDER 3242092 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIGENICS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 3B00195. THIS WAS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. NO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE, SO IT WAS NOT POSSIBLE TO EVALUATE IN ACCORDANCE WITH WORK INSTRUCTION. NO COMPLAINT SAMPLES WERE AVAILABLE SO WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT, NOR COMPLETE TESTING ON THE DRESSINGS FROM THE BATCH UNDER COMPLAINT. AS NO SAMPLES OR ADEQUATE IMAGES OF THE REPORTED ISSUE WERE RECEIVED, IT WAS NOT POSSIBLE TO OPEN AN NONCONFORMANCE (NC) OR CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) TO INVESTIGATE THIS ISSUE FULLY. PREVIOUS COMPLAINTS FOR FOREIGN MATTER INSECTS HAVE BEEN RECEIVED IN THE PAST, WITH AN NC OPENED TO INVESTIGATE THE ISSUE. WITHOUT THE SAMPLES AND ADEQUATE PHOTOGRAPHS OF THE COMPLAINT SAMPLES FOR THIS COMPLAINT, IT IS NOT POSSIBLE TO COMPLETE AN INVESTIGATION FOR THIS ISSUE SPECIFICALLY, BUT AS THE CONTAMINATION/FOREIGN MATTER APPEARS WAS DESCRIBED AS AN INSECT, THE PREVIOUS NC INVESTIGATION WILL BE RELEVANT. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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

    IT WAS REPORTED BY A RETAILER TO THE COMPANY'S REPRESENTATIVE THAT AN INSECT WAS FOUND BETWEEN THE DRESSING AND THE ADHESIVE ON (B)(6) 2023 PRODUCT WAS NOT USED. NO PHOTO WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329375 AQUACEL FOAM DRESSING, WOUND, HYDROPHILIC NAC CONVATEC LTD 420804 3B00195 00768455129089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown