BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEATWRAPS ADVANCED BACK PAIN THERAPY SIZE L-XL

    MDR report key: 8129097 · Received December 3, 2018

    Report

    Report Number
    MW5081807
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 28, 2018
    Report Date
    November 30, 2018
    Manufacturer
    PF CONSUMER HEALTHCARE 1 LLC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018, I USED THE SECOND OF TWO THERMACARE HEATWRAPS (ADVANCED BACK PAIN THERAPY, SIZE L-XL). I HAD USED THE FIRST ONE A MONTH EARLIER WITH NO ISSUE, AND UPON USING THE SECOND DISCARDED THE BOX IN OUR RECYCLING. I DON'T HAVE ANY INFORMATION FROM THE BOX, BUT I STILL WANT TO REPORT THAT THE PRODUCT DID BURN ME. IT HAS NEVER HAPPENED BEFORE. I ALWAYS USED IT AS INSTRUCTED AND DID SO AGAIN THIS TIME. I DID NOT HAVE IT DIRECTLY AGAINST MY SKIN - THERE WERE TWO THIN LAYERS OF CLOTHING BETWEEN IT AND MY SKIN, AND AFTER HAVING IT ON FOR FIVE TO SEVEN MINUTES, IT BEGAN TO BURN MY SKIN IN ONE AREA. ONE OF THE TOP CORNER CELLS WAS THE CULPRIT, AND IT HURT SO BADLY I HAD TO REMOVE IT AND DISPOSE OF IT PROPERLY. IT DID LOOK LIKE THE MATERIAL WAS THIN AND LOOSE WHERE THE CELLS WERE. I DID NOT REQUIRE MEDICAL ATTENTION BUT WILL BE THROWING AWAY THE OTHER THERMACARE WRAPS I HAVE ON HAND. ONE IS A BOX OF ADVANCED BACK PAIN THERAPY SIZE S-M, AND ANOTHER IS A BOX OF ADVANCED MENSTRUAL PAIN THERAPY. IT WOULD BE NICE TO RECEIVE A REFUND FOR THESE PRODUCTS AS I DON'T TRUST THEY ARE SAFE FOR ANYONE TO USE IN ANY WAY UNTIL THERMACARE HAS THE ISSUE COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963013 THERMACARE HEATWRAPS ADVANCED BACK PAIN THERAPY SIZE L-XL PACK, HOT, OR COLD, DISPOSABLE IMD PF CONSUMER HEALTHCARE 1 LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR