BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE MENSTRUAL HEAT

    MDR report key: 2922330 · Received January 11, 2013

    Report

    Report Number
    MW5028638
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 11, 2013
    Manufacturer
    PFIZER
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED A THERMACARE MENSTRUAL CRAMP RELIEF PATCHES AFTER HAVING MENSTRUAL CRAMPS. I PUT ON THE PATCH AS DESCRIBED IN THE INSTRUCTIONS AND FELL ASLEEP. I WOKE UP AND REMOVED THE PATCH. UPON REMOVING THE PATCH I NOTICED I HAD SEVERAL BURNS WHERE EACH OF THE HEAT CELLS WERE. I NOW HAVE INFECTED, OPEN SORES FROM THIS HEAT PATCH IN A VERY UNCOMFORTABLE AREA. DURATION: 5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18976 THERMACARE MENSTRUAL HEAT HEAT PATCH IMD PFIZER F31772 S

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other