BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE HEATWRAPS

    MDR report key: 751536 · Received August 9, 2005

    Report

    Report Number
    MW1036280
    Event Type
    Other
    Date Received
    August 9, 2005
    Date of Event
    August 7, 2005
    Report Date
    August 9, 2005
    Manufacturer
    P&G
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT USED "THERMACARE HEAT WRAP" -OTC- FOR LBP. PLACED WRAP ON LBP AND FELL ASLEEP WITH WRAP ON TILL NEXT MORNING -APPROXIMATELY 8 HOURS-. WRAP SLID DOWN AND RESTED ON HER BUTTOCK. RESULTED IN 6 BLISTER BURNS ON LEFT BUTTOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE HEATWRAPS HEATING PAD IMD P&G * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other