BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL EXTRA

    MDR report key: 10574256 · Received September 23, 2020

    Report

    Report Number
    1000317571-2020-00048
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 7, 2020
    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

    A BATCH RECORD REVIEW HAS BEEN COMPLETED AND INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL PM'S WERE COMPLETED. AFFECTED AMOUNT: 1PC. AQUACEL AG DRS 10X10CM WAS MANUFACTURED UNDER SAP CODE: 1182478 AND MANUFACTURING LOT NUMBER: 0A01776. LOT#: 0A01776 WAS STERILIZED UNDER LOT: 1238335011 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN-PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-030 VER.41.0 FOR MACHINE DOYEN 4. VISUAL INSPECTION IN ACCORDANCE WITH TM-002 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS RAISED DURING THE MANUFACTURING PROCESS OF LOT: 0A01776. 16 OCT 2020 - THERE ARE 2 COMPLAINTS FOR THE AFFECTED LOT CURRENTLY REGISTERED WITHIN TW8.7 AND APPEAR TO BE FOR THE SAME COMPLAINT ISSUE. 2 PHOTOGRAPHS HAVE BEEN RECEIVED FOR THE COMPLAINT ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPHS CONFIRM THE BATCH NUMBER, PRODUCT AND COMPLAINT ISSUE. EVENT (B)(4) WITH INVESTIGATION (B)(4) WERE RAISED FOR THIS ISSUE ON DOYEN 4. THE INVESTIGATION FOUND THAT IF THE DEAD PLATE IS SET TO GREATER THAN 176MM THIS CAN CAUSE THE DRESSINGS TO BE KNOCKED BACK INTO THE SEAL.. TRAINING HAS BEEN COMPLETED TO ENSURE THAT OPERATORS ARE AWARE OF THE CORRECT HEIGHT OF THE DEAD PLATE. NO FURTHER ACTION REQUIRED. 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

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

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 1. (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 THE DRESSING EXTENDS OUTSIDE THE PACKAGE WHICH CAUSED A LACK OF STERILITY. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039732 AQUACEL EXTRA DRESSING, WOUND, DRUG FRO CONVATEC LTD 420676 0A01776

    Patients

    Seq Age Sex Outcome Treatment
    1