BEUDAMED
    FDA Adverse Event Other Summary report: N

    2ND SKIN, NON-STICK, MOIST BURN PADS

    MDR report key: 158913 · Received March 19, 1998

    Report

    Report Number
    MW1013362
    Event Type
    Other
    Date Received
    March 19, 1998
    Date of Event
    March 16, 1998
    Report Date
    March 18, 1998
    Manufacturer
    SPENCO MEDICAL CORP.
    Product Code
    MGQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR PURCHASED 2ND SKIN NON-STICK MOIST BURN PADS TO USE ON A BURN ON THEIR LEFT HAND. RPTR PURCHASED IT SPECIFICALLY BECAUSE IT WAS NON-STICK AND CLAIMED TO SOOTHE THE PAIN & PROTECT THE BURN. RPTR APPLIED 1 PAD TO THE AREA & AS INSTRUCTED, COVERED IT WITH A STRETCH GAUZE! LATER THAT DAY (APPROX 8-10 HRS LATER) WHILE REMOVING THE GAUZE RPTR NOTICED THAT IT WAS STUCK LIKE GLUE TO THE BURN. RPTR TRIED TO REMOVE IT SLOWLY, AS THE PAIN WAS EXCRUCIATING. THE PRODUCT NOT ONLY STUCK TO THEIR BURN BUT ALSO REMOVED SKIN LAYERS & EXPOSED THE FATTY LAYER OF SKIN. AS A RESULT, RPTR HAS INCREASED PAIN, SUCEPTIBILITY TO INFECTION & IMPAIRED WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2ND SKIN, NON-STICK, MOIST BURN PADS MOIST, BURN PAD MGQ SPENCO MEDICAL CORP. * 75300

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other