BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE

    MDR report key: 548287 · Received July 10, 2004

    Report

    Report Number
    MW1032759
    Event Type
    Injury
    Date Received
    July 10, 2004
    Date of Event
    June 14, 2004
    Report Date
    July 1, 2004
    Manufacturer
    PROCTER & CAMBLE
    Product Code
    IMA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT USED A PRODUCT CALLED THERMACARE MADE BY PROCTER & GAMBLE. PT PLACED THE PRODUCT AROUND THEIR NECK AND THEN NOTICED ABOUT 1 HOUR LATER THAT THEIR SKIN WAS BURNING REALLY BAD. PT REMOVED THE PAD AND NOTICED THAT THE NECKLACE THEY WERE WEARING SLIPPED INTO THE PAD AND ACTED LIKE A HEAT SOURCE, WHICH CAUSED A SECOND DEGREE BURN. PT WROTE A LETTER TO THE CO LETTING THEM KNOW WHAT HAPPENED AND THAT A PRODUCT WARNING LABEL NEEDED TO BE ADDED TO THE PACKAGE, WARNING TO REMOVE ANY METAL IN THE AREA TO BE TREATED. THE CO RESPONED WITH A SIMPLE FORM LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE PAIN RELIEF PATCH IMA PROCTER & CAMBLE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R| S