BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE HEATWRAPS, MENSTRUAL(NOT APPLICABLE) WRAP 1APPLIC

    MDR report key: 1367833 · Received April 20, 2009

    Report

    Report Number
    1066015-2009-00002
    Event Type
    Other
    Date Received
    April 20, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 23, 2009
    Manufacturer
    WYETH CONSUMER HEALTHCARE
    Product Code
    OMW
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BURNT FAT CELLS [THERMAL BURN]. RED SKIN [ERYTHEMA]. FAT CORROCIOUS [UNEVALUABLE EVENT]. I USE THIS ON A CONSTANT BASIS, LIKE ALL THE TIME [DEVICE MISUSE]. CASE DESCRIPTION: THE PATIENT IS A (B) (6) FEMALE WHO USED A THERMACARE MENSTRUAL HEATWRAP TRANSDERMALLY FOR THE TREATMENT OF MENSTRUAL CRAMPS ON (B) (6) 2009. THE PATIENT EXPERIENCED "BURNT FAT CELLS" BELOW THE SKIN THAT WOULD REQUIRE PLASTIC SURGERY TO REPAIR. MEDICAL HISTORY INCLUDED SEVERE MENSTRUAL PROBLEMS. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B) (6) 2009, THE PATIENT BEGAN USING THERMACARE MENSTRUAL HEATWRAPS. THE PATIENT REPORTED REMOVING THE HEATWRAP AFTER AN UNSPECIFIED LENGTH OF TIME AND HER SKIN WAS RED. THE REDNESS DID NOT IMPROVE AND THE PATIENT CONTINUED USING THE WRAP EVERYDAY. A FEW DAYS LATER (AND "I USE THIS ON A CONSTANT BASIS, LIKE ALL THE TIME") SHE WENT TO THE DOCTOR. THE PHYSICIAN STATED THAT SHE HAD "FAT CORROCIOUS" WHICH IS BURNT FAT CELLS BELOW THE SKIN AND CAN ONLY BE TOTALLY CORRECTED THROUGH PLASTIC SURGERY. TREATMENT WAS NOT PROVIDED AND THE PATIENT HAS NOT RECOVERED. BURN ((B) (4)). REDNESS ((B) (4)). UNEVALUABLE EVENT ((B) (4)). DEVICE MISUSE ((B) (4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE HEATWRAPS, MENSTRUAL(NOT APPLICABLE) WRAP 1APPLIC DISPOSABLE PACK, HOT OMW WYETH CONSUMER HEALTHCARE 8289U018N

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Disability