BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMACARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP

    MDR report key: 2757878 · Received September 20, 2012

    Report

    Report Number
    1066015-2012-00039
    Event Type
    Other
    Date Received
    September 20, 2012
    Date of Event
    September 30, 2011
    Report Date
    October 11, 2011
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (02JUL2012): UPON FURTHER REVIEW, THIS CASE IS BEING UPGRADED TO A REPORTABLE MEDICAL DEVICE REPORT. NEW INFO FROM A CONTACTABLE ATTORNEY BY WAY OF CLAIM LETTER AND MEDICAL RECORDS INCLUDED: MEDICAL CONFIRMATION OF THE CASE, MEDICATION HISTORY ADVERSE ACTION DATA, INTERVENTION AND TREATMENT INFO, ADDED PRODUCT COMPLAINT ISSUE FOR GETTING TOO HOT, ADDED CODE OF DEVICE MISUSE AS THE PT DID NOT CHECK HER SKIN UNDER THE WRAP WHILE WEARING AND UPGRADED THE REPORT TO A REPORTABLE CASE.

    Description of Event or Problem · 1

    DID NOT CHECK UNDER HER SKIN WHILE WEARING THERMACARE HEATWRAP [DEVICE MISUSE]. ABSCESS, TRUNK [ABSCESS]. BURNING HER BACK AND EXPERIENCED PAIN [THERMAL BURN]. GETTING EXTREMELY HOT [PRODUCT QUALITY ISSUE]. DEVELOPED LOT OF BUMPS ON HER BACK [RASH PAPULAR]. COULD NOT SLEEP [INSOMNIA]. FELT TERRIBLE [FEELING ABNORMAL]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT BY A CONTACTABLE CONSUMER. THIS (B)(6) FEMALE PT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK AND HIP, WRAP) (LOT NUMBER: 6276787 4211063) FOR LOWER BACK PAIN ON (B)(6) 2011 (INITIALLY REPORTED AS (B)(6) 2011 WHICH IS A DISCREPANCY). SHE NOTED THAT SHE USED THE PRODUCT FOR ONE DAY IN A ROW, FOR TWO HOURS. RELEVANT MEDICAL HISTORY INCLUDED LUMBAR SURGERY IN 2001. UPON FOLLOW-UP, SHE NOTED SHE DOES NOT HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: DIABETES, POOR CIRCULATION HEART DISEASE, DIFFICULTY FEELING HEAT OR PAIN ON HER SKIN, RHEUMATOID ARTHRITIS, DECREASED SENSATION OR NEUROPATHY. SHE CLASSIFIED HER SKIN AS SENSITIVE AND THE TONE AS VERY LIGHT OR FAIR. ABNORMAL SKIN CONDITIONS CONCLUDED "CANNOT USE SUNTANS THING". SHE REPORTED NOT USING THERMACARE HEATWRAP IN THE PAST OR ANY OTHER HEAT PRODUCT FOR PAIN RELIEF, ALTHOUGH UPON FOLLOW-UP, SHE REPORTED USING THE HEATWRAP SINCE 2002. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, AFTER ONE HOUR OF USING THERMACARE HEATWRAP, SHE DEVELOPED SEVERE PAIN IN LOWER BACK AND IT WAS GETTING EXTREMELY HOT. SHE HAD MULTIPLE BUMPS ON HER LOWER BACK. SHE WAS UNABLE TO PUT ANY PRESSURE ON HER BACK, REQUIRING HER TO SIT FORWARD. SHE WORE SEVERAL LAYERS OF CLOTHING OVER THE PRODUCT AND REPORTED SHE ATTACHED THE ADHESIVE TO HER CLOTHING. SHE REPORTED THE DETAILS INCLUDING HOW LONG THE SITUATION OCCURRED, "FROM (B)(6) 2011 UNTIL NOW" (WHICH IS A DISCREPANCY FROM INITIALLY REPORTED ONSET OF (B)(6) 2011). ON (B)(6) 2011, THE PT REPORTED BURNING HER BACK, DEVELOPED MANY BUMPS ON HER BACK, WHICH WERE GETTING WORSE BECAUSE OF WHICH SHE COULD NOT SLEEP, EXPERIENCED PAIN AND FELT TERRIBLE. SHE CHECKED "NO" TO DID YOU ENGAGE IN EXERCISE WHILE USING THE PRODUCT; HOWEVER, THE NEXT QUESTION WAS, "IF YES, DESCRIBE THE ACTIVITY AND HOW LONG IT LASTED," HER REPLY WAS "WALKING." SHE DID NOT CHECK HER SKIN WHILE WEARING THE WRAP AND SHE DID READ THE USAGE INSTRUCTION BEFORE USING THE PRODUCT. SHE WAS NOT TAKING ANY MEDICATION DURING THE PROBLEM/SYMPTOMS. SHE REPORTS SHOWING THE "SUPERVISOR AT THE STORE HER BACK" AND CLAIMS THE PROBLEM IS A TISSUE BURN. SHE STATED, "I FELT MY BACK WAS VERY HOT BUT I DID NOT KNOW SO I ASK MY GIRLFRIEND TO LOOK AT MY BACK AND SHE SAID THAT ITS VERY BAD WITH LOTS OF BUMPS SO I COULD NOT SLEEP ON MY BACK AND I WENT TO THE HOSP. ON FOLLOW-UP, SHE DESCRIBED HER PROBLEM/SYMPTOMS AS "MY BACK HAVE A LOT OF BUMPS" AND STATES IT HAS LASTED "UNTIL NOW." THERAPEUTIC MEASURES TAKEN IN RESPONSE TO BURN HER BACK AND DEVELOPED LOT OF BUMPS ON HER BACK INCLUDED TREATMENT WITH UNSPECIFIED OINTMENT. UPON FOLLOW-UP, SHE REPORTED BEING UNDER THE CARE OF A PHYSICIAN FOR "MEDS FOR THE BURNS", AND SHE NOTED THAT SHE SOUGHT TREATMENT ON (B)(6) 2011. ON (B)(6) 2011, SHE WAS ADMITTED IN EMERGENCY ROOM WITH BACK PAIN-NON TRAUMATIC. THE THERMACARE HEATWRAP ON HER LOWER LUMBAR WAS BELIEVED TO HAVE CAUSED ALLERGIC REACTION AND PAIN TO AREA. HER SKIN EXAMINATION SHOWED ABNORMAL FINDINGS, WHICH INCLUDED ERYTHEMA, RASH, MULTIPLE ABSCESS OF DIFFERENT STAGES AND DISCHARGE FORM LOWER LUMBAR, SKIN LESIONS AND NO PRURITUS. HER MUSCULOSKELETAL EXAMINATION WAS POSITIVE FOR TENDERNESS WHEN THE BACK WAS PALPATED AND SWELLING. ON THE SAME DAY, SHE WAS DIAGNOSED WITH ABSCESS, TRUNK. THE EMERGENCY ROOM TREATMENT INCLUDED THE WOUNDS WERE CLEANED AND IRRIGATED THEN ANESTHETIZED WITH TOPICAL "PAIN EASE" WHICH PROVIDED GOOD RELIEF. SMALL INCISION WAS MADE WITH BLADE (SIZE NUMBER 11) TO THREE SEPARATE ABSCESS OF THE LEFT LOWER LUMBAR, PUS EXPRESSED FOR ALL THE WOUNDS AND BACITRACIN DEPRESSING PLACED OVER ALL WOUNDS, "SCARS" REMOVED FROM THE WOUNDS AND GIVEN FOR THE CULTURE (UNK RESULTS). SHE WAS ALSO TREATED WITH IBUPROFEN 600 MG TABLET ORALLY AND SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) 800MG-160MG TABLET ORALLY. SHE WAS DISCHARGED TO HOME ON STABLE CONDITION ON THE SAME DAY FROM EMERGENCY DEPT WITH THE PRESCRIPTIONS OF HYDROCODONE, PARACETAMOL (VICODIN) 5MG-500MG TABLET AND SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) TABLET. FOR THE PROBLEM, HYDROCODONE APAPS 5-500MG AND SMZ-TMP DS 500" WER NOTED (FREQUENCY/START AND STOP DATES NOT PROVIDED). SHE STATED SHE WAS "SUPPOSED TO GOING TO OTHER DOCTOR BUT I DON'T HAVE INSURANCE." (AN INVOICE VERIFIED AN ER VISIT ON (B)(6) 2011, AND LAB DATA/TESTS WERE NOT NOTED ON SAME.) ON (B)(6) 2011, SHE STOPPED USING HEATWRAP IN RESPONSE TO THE ABOVE-MENTIONED EVENTS. AT THE TIME OF THE REPORT, SHE WAS NOT USING THE HEATWRAP, AND THE PRODUCT HAD BEEN DISCARDED. AT THE TIME OF THE INITIAL REPORT, SHE HAD NOT RECOVERED FROM THE ABOVE-MENTIONED EVENTS, ALTHOUGH ON FOLLOW-UP, SHE NOTED THAT HER BACK HAD MANY BUMPS BUT THAT IT WAS "GETTING A LITTLE BETTER." AS OF (B)(6) 2012, THE CLINICAL OUTCOME OF THE EVENT ABSCESS TRUNK WAS UNK. FOLLOW-UP ((B)(6) 2011): THIS SPONTANEOUS FOLLOW-UP REPORT WAS RECEIVED FROM A CONTACTABLE CONSUMER. NEW INFO INCLUDED TREATMENT, DETAILS ABOUT PRODUCT USE, MEDICAL HISTORY, ONSET DATE, PAST PRODUCT USE, AND OUTCOME. FOLLOW-UP # 02 (23DEC2011): THIS IS A FOLLOW-UP SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. NEW INFO INCLUDED ETHNICITY, INITIATION OF THERAPY AND DATE OF BIRTH. FOLLOW-UP (30DEC2011): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFO EXPECTED. FOLLOW-UP (03JAN2012): NEW INFO RECEIVE FROM THE CONTACTABLE CONSUMER. THE PT PROVIDED THE EMERGENCY ROOM BILL AND REQUESTED REIMBURSEMENT. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFO EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE 6276787 4211063

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R