BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE HEATWRAPS, BACK & HIP, SIZE L/XL

    MDR report key: 808788 · Received January 17, 2007

    Report

    Report Number
    1066015-2007-00001
    Event Type
    Other
    Date Received
    January 17, 2007
    Date of Event
    October 18, 2006
    Report Date
    November 1, 2006
    Manufacturer
    P&G PAPER PRODUCT CO
    Product Code
    IMD
    PMA / PMN Number
    (us) otc dev
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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. RECEIVED CONSUMER'S FOLLOW-UP QUESTIONNAIRE: THE CONSUMER REPORTED THAT SHE USED THERMACARE PAIN RELIEVING HEATWRAPS, BACK, SIZE L/XL WRAP 1 APPLIC, WHILE WEARING A LIGHT NIGHTSHIRT, TO TREAT "MUSCULAR PAIN IN RIGHT HIP AND THIGH"; WHEN SHE REMOVED THE WRAP, SHE NOTICED A CHEMICAL BURN FROM ONE OF THE OVAL AREAS ON THE WRAP; THE BURN WAS ONE INCH IN DIAMETER, VERY DEEP AND PAINFUL AND SHE HAD A HARD TIME SLEEPING AND WALKING. THE CONSUMER VISITED A PHYSICIAN; TREATMENT CONSISTED OF DAILY CLEANSING, AN UNSPECIFIED PRESCRIBED ANTIBIOTIC PILL, SILVER SULFADIAZINE AND THE AREA WAS KEPT COVERED WITH A BAND-AID. THE CASE OUTCOME WAS IMPROVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY-NONE REPORTED, MEDICAL HISTORY- "HORMONE REPLACEMENT THERAPY". CONCOMITANT MEDICATIONS INCLUDED: MEDROXYPROGESTERONE 5MG, 1 /DAY AND ESTRADIOL 2 MG, 1 /DAY FOR "HORMONE REPLACEMENT THERAPY". OTHER PRODUCTS USED PREVIOUSLY WITHOUT INCIDENT : YES - SMALL THERMACARE PATCH FOR JOINT PAIN IN HAND FOR TWO OR THREE DAYS IN 2006; ELECTRIC HEATING PADS FOR PAIN RELIEF- MANY TIMES, FOR SEVERAL DAYS. THE CONSUMER MENTIONED SHE WAS WEARING THE THERMACARE WRAP WHILE LYING ON HER LEFT SIDE. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS AN INITIAL SERIOUS DEVICE REPORT WHERE THE CONSUMER USED THERMACARE PAIN RELIEVING HEATWRAPS AND REPORTED THAT SHE EXPERIENCED A SECOND DEGREE BURN. THE CONSUMER REPORTED AFTER SELF-TREATING THE BROKEN BLISTER WITH NEOSPORIN AND BANDAGES FOR TWO WEEKS, SHE VISITED HER PHYSICIAN. MEDICAL RECORDS FOR PHYSICIAN ASSISTANT VISITS ON THREE SEPARATE DATES INDICATED THAT THE CONSUMER HAD A PARTIAL THICKNESS BURN ON RIGHT THIGH WITH INFECTION AND TREATMENT INCLUDED DEBRIDEMENT AND KEFLEX. PHYSICIAN ASSISTANT OFFICE NOTE ON 2006 INDICATED THAT THE ANNULAR LESION WITH DRY YELLOW ESCHAR ON TOP WAS HEALING NICELY WITH SURROUNDING TISSUE SLIGHTLY PINK AND NO SIGNS OF INFECTION. NARRATIVE: A CONSUMER REPORTED THAT THEY USED THERMACARE PAIN RELIEVING HEATWRAPS, BACK, SIZE L/XL WRAP 1 APPLIC BEFORE BED, 1/DAY FOR 1 DAY AND RECEIVED A SECOND DEGREE BURN; SHE AWOKE SEVEN HOURS LATER TO FIND AN INTACT BLISTER ON HER RIGHT UPPER LEG APPROX THE SIZE OF A QUARTER; THE AREA WAS RED AND BURNING. SHE REPORTED THAT THE BLISTER QUICKLY BROKE AND SHE WAS DOCTORING THE AREA HERSELF BY APPLYING NEOSPORIN OINTMENT AND BANDAGES FOR APPROX TWO WEEKS UNTIL SHE REALIZED THAT THE AREA WAS NOT HEALING AND WAS OOZING A DISCOLORED LIQUID. THE CONSUMER VISITED HER PHYSICIAN WHO PRESCRIBED KEFLEX, SILVER SULFADIAZINE AND BANDAGES TO TREAT HER SECOND DEGREE BURNS AND INFECTION. SHE REPORTED THAT SHE WAS RE-EVALUATED BY HER PHYSICIAN AND HE STATED THAT HEALING WAS NOTED, HOWEVER, SLOW AND INADEQUATE. SHE REPORTED THAT SHE WILL BE EVALUATED AND IF HEALING WAS NOT NOTED, SHE WILL BE REFERRED FOR PLASTIC SURGERY CONSULTATION FOR POSSIBLE SKIN GRAFT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY-NONE REPORTED, MEDICAL HISTORY-NONE REPORTED. CONCOMITANT MEDICATIONS INCLUDED: MEDROXYPROGESTERONE, ESTRADIOL. 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 5094U018B

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention