BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEPILEX AND/OR MEPILEX AG

    MDR report key: 3457420 · Received October 30, 2013

    Report

    Report Number
    3004763499-2013-00019
    Event Type
    Death
    Date Received
    October 30, 2013
    Date of Event
    March 28, 2013
    Report Date
    October 29, 2013
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A DOUBLE-BLINDED, COMPARATIVE, SUPERIORITY, MULTI-CENTER CLINICAL INVESTIGATION OF MEPILEX AND MEPILEX AG CONDUCTED IN (B)(4). BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. AS THIS WAS A DOUBLE-BLINDED STUDY WE ARE NOT AT THIS TIME SURE OF WHICH OF THE DEVICES WAS USED ON THIS SUBJECT. THEREFORE, WE HAVE REPORTED ON BOTH PRODUCTS. NO ADD'L PT / EVENT INFO HAS BEEN PROVIDED TO DATE. THE INVESTIGATORS ASSESSMENT OF RELATIONSHIP OF SUBJECT INCIDENT RELATION TO PRODUCT IS UNLIKELY. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT WAS ENROLLED IN A DOUBLE-BLINDED, COMPARATIVE, SUPERIORITY, MULTI-CENTER CLINICAL INVESTIGATION OF MEPILEX AND MEPILEX AG. THE SUBJECT DIED FROM CARDIAC DECOMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556127 MEPILEX AND/OR MEPILEX AG MEPILEX AND/OR MEPILEX AG FRO MOLNLYCKE HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death