BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEATWRAP ADVANCED BACK PAIN THERAPY, L/XL

    MDR report key: 8110592 · Received November 27, 2018

    Report

    Report Number
    MW5081643
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 25, 2018
    Report Date
    November 26, 2018
    Manufacturer
    PFIZER INC.
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED THERMACARE BACK PAIN THERAPY HEAT WRAP FOR 6 HRS AS DIRECTED, EXPERIENCED SUNBURN AND RASH LIKE SIDE EFFECTS THE NEXT DAY. HOW WAS IT USED OR TAKEN? TOPICAL. THERAPY DURATION: 6 HOUR. REASON FOR USE: BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946428 THERMACARE HEATWRAP ADVANCED BACK PAIN THERAPY, L/XL PACK, HOT OR COLD, REUSABLE IME PFIZER INC. W91247

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR