BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEPILEX AG

    MDR report key: 1852407 · Received September 28, 2010

    Report

    Report Number
    3004763499-2010-00003
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Product Code
    FRO
    PMA / PMN Number
    K071354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH DOCUMENTATION HAS BEEN INVESTIGATED AND THERE WERE NOT ANY DEVIATIONS. SAMPLES WERE NOT AVAILABLE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    PT WENT TO THE EMERGENCY ROOM WITH ANAPHYLACTIC SHOCK SEVERAL HOURS AFTER WOUND CARE NURSE CHANGED THE DRESSING ON A CHRONIC WOUND. THE STEPS TAKEN DURING THE DRESSING CHANGE WAS: RINSED AROUND THE EDGES OF THE WOUND WITH BETADINE, THEN RINSED WITH A WOUND CLEANSER THAT HAS BEEN USED SEVERAL TIMES IN THE PAST, THEN APPLIED A PROMOGRAN AND COVERED IT WITH A MEPILEX AG. FOUR TO FIVE PIECES OF THE MEPILEX AG WAS APPLIED. PT HAS NO HISTORY OF SILVER ALLERGY. BASED ON INTERNAL INVESTIGATION, THEY DETERMINED THE ANAPHYLAXIS WAS DUE TO THE BETADINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEPILEX AG MEPILEX AG FRO MOLNLYCKE HEALTHCARE NOT KNOWN 10121750

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization