BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE MENSTRUAL (THERMACARE HEATWRAP) WRAP

    MDR report key: 2102002 · Received May 19, 2011

    Report

    Report Number
    1066015-2011-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Report Date
    May 11, 2011
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BURNS ON HER SKIN THAT WAS OF HER PALM SIZE [THERMAL BURN]. CASE DESCRIPTION: THIS IS AN INITIAL SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS CURRENTLY (B)(6) FEMALE, CONSUMER, STARTED TO USE HEAT WRAP (THERMACARE MENSTRUAL PATCH) SINCE (B)(6) 2011 FOR MENSTRUAL PAIN. NO RELEVANT MEDICAL HISTORY AND RELEVANT CONCOMITANT MEDICATIONS. THE CONSUMER HAD USED HEAT WRAP IN THE PAST BUT THIS WAS FIRST TIME WHEN SHE HAD USED HEAT WRAP FOR MENSTRUAL PAIN. THE CONSUMER REPORTED THAT WHEN SHE USED THE WRAP FOR MENSTRUAL PAIN, AFTER 2 OR 3 DAYS OF USING IT, SHE EXPERIENCED BURNS ON HER SKIN THAT WERE OF HER PALM SIZE AND THAT LOOKED LIKE A SCAR. THE CONSUMER DID NOT USE THE PRODUCT OVERNIGHT OR WHILE SLEEPING. THE CONSUMER WORE EACH WRAP FOR 6 HOURS. THE CONSUMER HAD NO OTHER ASSOCIATED SYMPTOMS LIKE PAIN, FEVER, RASH AND SWELLING. THERE WERE NO DEFECTS IN THE PRODUCT LIKE CUTS AND TEARS. THE CONSUMER HAD STOPPED USING THE HEAT WRAP SINCE (B)(6) 2011. THERE WERE NO THERAPEUTIC MEASURES TAKEN IN RESPONSE TO THE REPORTED EVENT. THE CONSUMER HAD NOT RECOVERED FROM THE REPORTED EVENT AT THE TIME OF REPORT. THE CONSUMER WAS USING THE HEAT WRAP UNDER THE CARE OF A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE MENSTRUAL (THERMACARE HEATWRAP) WRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1