BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLPATCH

    MDR report key: 4925865 · Received July 15, 2015

    Report

    Report Number
    1320681-2015-00010
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 15, 2015
    Manufacturer
    THE MENTHOLATUM COMPANY
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WORE DISPOSABLE HEAT WARMING PATCH ON BACK FOR PAIN RELIEF. SHE REMOVED THE PATCH AFTER 4-5 HOURS DUE TO ITCHING AND SUBSEQUENTLY DEVELOPED LARGE BLISTERS. SHE SAW HER PHYSICAL THERAPIST 2 DAYS LATER AND WAS ADVISED THAT SHE HAD RECEIVED 2ND AND 3RD DEGREE BURNS. CONSUMER SELF-MEDICATED WITH PRESCRIPTION MEDICATION (FENTANYL PATCH 75 MG AND ZANAFLEX 4 MG) HER SKIN HAS HEALED BUT NOW CLAIMS TO HAVE PERMANENT SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460786 WELLPATCH PACK, HOT OR COLD, DISPOSABLE IMD THE MENTHOLATUM COMPANY 1402B9

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other CHANTEX 1MG 2X/DAY| METFORMIN 1000MG 2X/DAY| CLONAZEPAM 1MG 2X/DAY| LEVETIRACETAM 500MG 2X/DAY| PRILOSEC| ZANAFLEX