BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0900 - AQUACEL AG

    MDR report key: 11207258 · Received January 21, 2021

    Report

    Report Number
    1000317571-2021-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    January 20, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    FRO
    PMA / PMN Number
    K121275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(6). A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL PMS WERE COMPLETED WITH NO DISCREPANCIES. AFFECTED AMOUNT: 1PC. AQUACEL AG EXTRA 10X10CM WAS MANUFACTURED UNDER LOT NUMBER 0G00152. LOT # 0G00152 WAS STERILIZED UNDER LOT 1245739311 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-030 VER. 44.0 FOR DOYEN 4. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 0G00152. TWO COMPLAINTS HAVE BEEN RECEIVED FOR THE AFFECTED LOT FOR THE SAME COMPLAINT ISSUE. NO PHOTOGRAPH WAS RECEIVED HOWEVER SAMPLES FROM THE DISTRIBUTION CENTER WERE RECEIVED AND WERE TESTED. AN INVESTIGATION WAS RAISED FOR THIS COMPLAINT ISSUE. THE ROOT CAUSE WAS FOUND TO BE ABSENCE OF CHLORIDE (CL-) IONS IN THE DRESSINGS. THE EFFICACY OF THE DRESSINGS HOWEVER IS NOT AFFECTED. NO FURTHER ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE1000317571.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PATIENT COUNTRY: (B)(6). AFFILIATION: (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "WHEN PACKET WAS OPEN DRESSING APPEARED BROWN AND DIRTY IN PLACES." THE PRODUCT WAS NOT USED. NO PHOTO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107468 L3W0900 - AQUACEL AG DRESSING, WOUND, DRUG FRO CONVATEC LTD 420676 0G00152

    Patients

    Seq Age Sex Outcome Treatment
    1