BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE HEATWRAPS, BACK & HIP, SIZE L/XL

    MDR report key: 814242 · Received February 6, 2007

    Report

    Report Number
    1066015-2007-00002
    Event Type
    Other
    Date Received
    February 6, 2007
    Report Date
    October 27, 2006
    Manufacturer
    P&G PAPER PRODUCT CO
    Product Code
    IMD
    PMA / PMN Number
    otc device
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LOT NUMBER PROVIDED AND BATCH RETAIN INVESTIGATION PENDING. PRODUCT REQUESTED FROM CONSUMER, BUT NOT RECEIVED TO DATE, THEREFORE, UNABLE TO PROCEED WITH DEVICE EVALUATION.

    Description of Event or Problem · 1

    THIS IS AN INITIAL SERIOUS DEVICE REPORT WHERE A CONSUMER REPORTED THAT SHE USED THERMACARE PAIN RELIEVING HEATWRAPS TO TREAT BACK PAIN AND EXPERIENCED A BURN WITH BLISTERS. THE CONSUMER REPORTED THAT SHE VISITED HER PHYSICIAN, WHO TOLD HER THAT SHE HAD VERY BAD THIRD DEGREE BURNS. MEDICAL RECORDS PROVIDED BY HER PLASTIC SURGEON (PHYSICIAN) REVEALED THAT THE CONSUMER HAD THIRD DEGREE BURNS OF THE RIGHT AND LEFT UPPER BUTTOCKS WITH INFLAMMATION AND PAIN. SUBSEQUENT TREATMENT RENDERED BY THE PLASTIC SURGEON INCLUDED DEBRIDEMENT OF BOTH ESCHARS DOWN TO BLEEDING TISSUE. MEDICAL RECORDS REVEALED THAT TEN DAYS POST DEBRIDEMENT, THE CONSUMER WAS STILL COMPLAINING OF MILD PAIN; HOWEVER, THE BURN WOUNDS WERE COMPLETELY HEALED WITH MODERATE ERYTHEMA FROM REMAINING INFLAMMATION. NARRATIVE: A CONSUMER REPORTED THAT THEY, A FEMALE, USED THERMACARE PAIN RELIEVING HEATWRAPS, BACK, SIZE L/XL WRAP 1 APPLIC FOR 5 HOURS, 13:30 THROUGH 18:30, 1 ONLY FOR 1 DAY IN 2006 AND WHEN SHE REMOVED THE WRAP SHE WAS ALL BURNED; THE AREA WAS HURTING, SHE FELT LIKE A PUNCHING BURNING SO SHE CALLED HER DAUGHTER WHO TOLD HER THAT IT LOOKED LIKE SHE HAD A BAD BURN. THE CONSUMER REPORTED THAT HER DAUGHTER DRESSED AND PUT GAUZE ON THE AREA; SHE HAD RED SKIN AND THREE BLISTERS APPROX THE SIZE OF A HALF DOLLAR. THE CONSUMER REPORTED THAT SHE HAD A NORMAL APPOINTMENT WITH HER SKIN DOCTOR A WEEK LATER AND HE SAID THAT HE WOULD BE HAPPY TO LOOK AT THE AREA; HE TOLD HER THAT SHE HAD VERY BAD THIRD DEGREE BURNS AND ADVISED HER TO DRESS THE AREA WITH BACITRACIN AND COVER IT WITH GAUZE TWICE DAILY AND TO RETURN FOR FOLLOW-UP IN 2 WEEKS. SHE REPORTED THAT HER DAUGHTER SAID THAT THE AREA WAS GETTING BETTER; AT LEAST ONE OF THE BLISTERS WAS NOW A SCAB AND SHE WAS NOT SURE OF THE OTHERS (SHE COULD NOT SEE THE AREA). THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: DRUG ALLERGY-"PENICILLIN", ALLERGY-UNKNOWN, MEDICAL HISTORY-"HIGH BLOOD PRESSURE", "THYROID", "NERVE PROBLEMS". CONCOMITANT MEDICATIONS INCLUDED: AVALIDE, LEVOTHYROXINE, DETROL LA. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE HEATWRAPS, BACK & HIP, SIZE L/XL DISPOSABLE PACK, HOT IMD P&G PAPER PRODUCT CO UNK 4145U018B

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LEVOTHYROXINE (LEVOTHYROXINE)| DETROL LA (TOLTERODINE L-TARTRATE)