BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE, LOWER BACK & HIP (NOT APPLICABLE) WRAP

    MDR report key: 1931534 · Received November 19, 2010

    Report

    Report Number
    1066015-2010-00007
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    May 1, 2007
    Report Date
    November 10, 2010
    Manufacturer
    WYETH CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BURN, 2ND TO 3RD DEGREE [BURNS THIRD DEGREE]. BURN, 2ND TO 3RD DEGREE [BURNS SECOND DEGREE]. DISCOMFORT [DISCOMFORT]. WEEPING [WOUND SECRETION]. RAW FLESH [OPEN WOUND]. FORMATION OF BLISTERS [BLISTER]. CASE DESCRIPTION: INFO WAS RECEIVED FROM A PHARMACIST VIA A REGULATORY AUTHORITY CONCERNING A (B)(6) FEMALE CONSUMER IN (B)(6) WHO USED A THERMACARE LOWER BACK AND HIP (8HR) HEATWRAP TRANSDERMALLY FOR BACK PAIN. DURING (B)(6)2007, THE PT APPLIED A HEATWRAP FOR 6 HOURS. SHE THEN EXPERIENCED 2ND TO 3RD DEGREE BURNS (BURNS SECOND DEGREE/SECOND DEGREE BURNS) (BURNS THIRD DEGREE/THIRD DEGREE BURNS) ON THE LOWER BACK, WHICH WERE THE SIZE OF THE WRAP. BLISTERS (BLISTER/BLISTERS) ALSO FORMED. THE WOUNDS WERE WEEPING (WOUND SECRETION/WOUND WEEPING) UNTIL THE FLESH WAS RAW (OPEN WOUND/OPEN WOUND). THE PT WAS TREATED WITH PAIN KILLERS AND OINTMENT DRESSINGS FOR 5 MONTHS BY A PHYSICIAN. SURGICAL INTERVENTION SUCH AS DEBRIDEMENT WAS NOT REQUIRED AND THE PHARMACIST DID NOT EXPECT THE PT TO EXPERIENCE LONG TERM SEQUELAE SUCH AS SCARRING. IT WAS NOTED THAT AFTER 5 MONTHS OF DISCOMFORT (DISCOMFORT/DISCOMFORT) THE PT RECOVERED. MEDICAL HISTORY INCLUDED LUNG EMBOLISM, DIABETES, POOR CIRCULATION AND RHEUMATOID ARTHRITIS. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE, LOWER BACK & HIP (NOT APPLICABLE) WRAP NONE IMD WYETH CONSUMER HEALTHCARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other INSULIN (INSULIN) INJECTION| KALINORM-RETARD P (POTASSIUM CHLORIDE) TABLET| FURORESE (FUROSEMIDE) CAPSULE| MARCUMAR (PHENPROCOUMON) TABLET ONGOING