BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERCEL NON ADHERENT ALGINATE DRESSING

    MDR report key: 8173503 · Received December 18, 2018

    Report

    Report Number
    8044178-2018-00003
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS GROUP PLC
    Product Code
    FRO
    PMA / PMN Number
    K081363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF THE COMPLAINT, A REVIEW OF THE ROUTINE QC TESTING OF THE INTERMEDIATES USED IN LOT W00029400 WAS PERFORMED AND ALL RESULTS, INCLUDING ABSORBENCY, WERE WITHIN SPECIFICATION. A REVIEW OF THE BATCH RECORDS FOR LOT W00029400 AND THE INTERMEDIATES CONSUMED WITHIN THIS LOT WAS CONDUCTED AND NO ISSUES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THIS DEFECT.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED STATING THAT A CUSTOMER REPORTED THAT SILVERCEL NON ADHERENT ABSORBS AND SPREADS EXUDATE, CAUSING MACERATION OF MARGIN. THIS EVENT OCCURS EVEN BEFORE THE SATURATION OF THE DRESSING, THE CUSTOMER REPORTS THE ISSUE IS NOT LOT SPECIFIC, BUT AFFECTING LONG TERM EXPERIENCE WITH MULTIPLE PATIENTS OVER A PERIOD OF TIME, SINCE THEY STARTED USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016549 SILVERCEL NON ADHERENT ALGINATE DRESSING SILVERCEL NON ADHERENT ALGINATE DRESSING FRO ADVANCED MEDICAL SOLUTIONS GROUP PLC N/A W00029400

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other