BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEAT WRAP

    MDR report key: 8826330 · Received July 24, 2019

    Report

    Report Number
    MW5088358
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    PF CONSUMER HEALTHCARE 1 LLC
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BROUGHT AND USED A THERMACARE HEAT WRAP THAT BURNED AND BLISTERED MY CHEST AND NECK. I DO NOT HAVE THE MONEY TO SEE A DR, SO I AM SUFFERING WITH IT. IT HURTS. AND IT ALSO LOOKS DISGUSTING. BECAUSE I CAN'T SEE A DR, I DON'T KNOW WHAT TO DO TO TREAT IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618652 THERMACARE HEAT WRAP PACK, HOT OR COLD, DISPOSABLE IMD PF CONSUMER HEALTHCARE 1 LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other