BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP HEAT WRAP

    MDR report key: 8591056 · Received May 7, 2019

    Report

    Report Number
    MW5086444
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    March 13, 2019
    Report Date
    May 4, 2019
    Manufacturer
    PFIZER CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THERMACARE HEAT WRAP, LOT T81953, 12/28, EXP 11/2020, CAUSED BURNS / BLISTERS LAST MARCH. I HEALED. I THOUGHT IT WAS UNIQUE TO ME BUT NOTICED THEY HAVE A RECALL ON A DIFFERENT LOT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378488 THERMACARE LOWER BACK AND HIP HEAT WRAP PACK, HOT OR COLD DISPOSABLE IMD PFIZER CONSUMER HEALTHCARE T81953

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR