BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE L/XL

    MDR report key: 416759 · Received September 12, 2002

    Report

    Report Number
    MW1026168
    Event Type
    Other
    Date Received
    September 12, 2002
    Date of Event
    September 7, 2002
    Report Date
    September 12, 2002
    Manufacturer
    PROCTOR AND GAMBLE
    Product Code
    IMA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    "THERMACARE" HEAT WRAP WAS USED AS INDICATED ON PACKAGE FOR 8 HRS. AN AREA OF SKIN SUSTAINED A BURN. BURN AREA WAS THE SIZE OF TWO OF THE DISCS FOUND IN THE WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE L/XL HEAT WRAP IMA PROCTOR AND GAMBLE * 1100U0188

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other