BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE

    MDR report key: 1942158 · Received December 24, 2010

    Report

    Report Number
    MW5018726
    Event Type
    Injury
    Date Received
    December 24, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 24, 2010
    Manufacturer
    THERMACARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED THERMACARE MENSTRUAL HEAT THERAPY AND RECEIVED FOUR LARGE SKIN BLISTERS ON MY SKIN. DATES OF USE: 5 HOURS ON (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: PERIOD CRAMPS. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE NONE IMD THERMACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other