BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRESSING,WOUND,HYDROPHILIC

    MDR report key: 10715620 · Received October 21, 2020

    Report

    Report Number
    1000317571-2020-00153
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 24, 2020
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND THEY WERE ALL COMPLETED WITH NO DISCREPANCIES. AFFECTED AMOUNT: 18PCS. AQUACEL DRS 5X5CM WAS MANUFACTURED UNDER SAP CODE: 1161262 AND MANUFACTURING LOT NUMBER: 0F01132. LOT#: 0F01132 WAS STERILISED UNDER LOT: 1244656811 AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN-PROCESS TESTING AND PACKAGING OF PRODUCTS AS RUN IN ACCORDANCE WITH PI12-027 VER. FOR MACHINE DOYEN 3. 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 NONCONFORMITIES WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT: 0F01132. THERE ARE 3 COMPLAINTS FOR THIS LOT WITHIN TW8.7 HOWEVER ARE FOR DIFFERENT COMPLAINT ISSUES. 3 PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPHS CONFIRM THE EXPECTED PRODUCT AND BATCH. THEY ALSO CONFIRM THE EXPECTED COMPLAINT ISSUE. THE ISSUE IS CAUSED BY DRESSINGS CATCHING ON THE VISION SYSTEM LIGHT BOX COVER, BUNCHING UP AND MOVING INTO THE WELD AREA. A CCR (CCR-DMR-00188) IS CURRENTLY BEING COMPLETED FOR A NEW VISION SYSTEM WHICH WILL INCLUDE A NEW LIGHT BOX AND GUARD. THIS WILL ERADICATE THE ISSUE FOUND WITHIN THIS COMPLAINT. OPERATIONS HAVE BEEN INFORMED OF THE COMPLAINT ISSUE. 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 12 OF 18. BRAND NAME: AQUACEL/ AQUACEL AG SURGICAL COVER DRESSING. COMPLAINANT CITY: (B)(6). COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT PHONE: (B)(6). PATIENT COUNTRY: (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 PRODUCT WAS CAUGHT IN THE SEAL. 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
    1180369 DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LTD 177901 0F01132

    Patients

    Seq Age Sex Outcome Treatment
    1