BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE MUSCLE PAIN THERAPY

    MDR report key: 8133609 · Received December 4, 2018

    Report

    Report Number
    MW5081842
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    October 22, 2018
    Report Date
    December 4, 2018
    Manufacturer
    PFIZER, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT A RED LINING WHERE PATCH WAS PLACED THAT STARTED TO BURN AND THEN THE NEXT DAY IT WAS BLISTERED AND THEN AFTER THAT IT TURNED INTO A NASTY SCAB. SKIN RASH THAT BURNED. THERAPY DATE: (B)(6) 2018. REASON FOR USE: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968046 THERMACARE MUSCLE PAIN THERAPY PACK, HOT OR COLD, DISPOSABLE IMD PFIZER, INC. S 68516

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| S