BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE

    MDR report key: 12324630 · Received August 13, 2021

    Report

    Report Number
    MW5103232
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    August 4, 2021
    Manufacturer
    PF CONSUMER HEALTHCARE 1 LLC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THERMACARE BACK WRAP AND PLACED IT ON LOWER BACK FOR 8 HOURS, AND IT CAUSED 2ND DEGREE BURN MY ENTIRE LOWER BACK WHICH NEEDED MEDICAL ATTENTION. BACK PAIN. ISSUED BY WORKER COMPENSATION PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214527 THERMACARE PACK, HOT OR COLD, DISPOSABLE IMD PF CONSUMER HEALTHCARE 1 LLC EE3305

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention