BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE HEATWRAPS, VERSION UNK

    MDR report key: 1135463 · Received August 8, 2008

    Report

    Report Number
    1066015-2008-00005
    Event Type
    Other
    Date Received
    August 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 17, 2008
    Manufacturer
    P & G PAPER PRODUCT CO.
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD AND/OR BATCH LOT INFO WAS NOT PROVIDED. THEREFORE, UNABLE TO PROCEED WITH DEVICE EVAL.

    Description of Event or Problem · 1

    THIRD DEGREE BURN, BURN THROUGH ALL LAYERS OF SKIN IN A LINE OF CIRCLES APPROX 1.5 - 2 CM. [BURNS THIRD DEGREE]. CASE DESCRIPTION: A REP FROM A REG AUTHORITY REPORTED THAT A PHYSICIAN REPORTED A CONSUMER USED THERMACARE HEATWRAPS, VERSION UNK, TO TREAT "LOW BACK PAIN" AND DEVELOPED THIRD DEGREE BURN, BURN THROUGH ALL LAYERS OF SKIN IN A LINE OF CIRCLES APPROX 1.5 - 2CM BEGINNING IN 2008. A PHYSICIAN WAS VISITED. THE CASE OUTCOME WAS RECOVERED. THE CONSUMER DISCONTINUED USE OF THE PROD. PAST MEDICAL HISTORY INCLUDED: ALLERGY - UNK, MEDICAL HISTORY - UNK. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE HEATWRAPS, VERSION UNK * IMD P & G PAPER PRODUCT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other