BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP HEAT WRAP

    MDR report key: 20957296 · Received December 17, 2024

    Report

    Report Number
    3007593958-2024-00056
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 28, 2024
    Report Date
    January 13, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANGELINI S.P.A. FORWARDED THE FOLLOWING REPORT TO BRIDGES CONSUMER HEALTHCARE ON (B)(6)2025. ANGELINI S.P.A. RECEIVED THE INFORMATION ON (B)(6)2024. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON (B)(6)2024 FROM QA DEPARTMENT COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF LOWER BACK HIP (LBH) 8HR PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED. THE TREND ANALYSIS RETURNED A TOTAL OF (B)(4) COMPLAINTS FOR LBH 8 HOUR PRODUCTS DURING THE PERIOD (B)(6)2021 TO (B)(6)2024 FOR THE CLASS/SUBCLASS. NONE OF THE COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE PPM FOR THIS COMPLAINT IS 1.73 PPM, WHICH IS WITHIN THE CONTROL LIMIT FOR THIS SUBCLASS AND PRODUCT TYPE. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE LBH 8HR PRODUCTS. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE BURNS IN THE HAZARD ANALYSIS (RPT-000097160). THERE ARE MITIGATIONS IN PLACE TO PREVENT THESE SITUATIONS SUCH AS IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTIONS TO ENSURE THE QUALITY AND SAFETY OF THE PRODUCT. THERE ARE ALSO MULTIPLE RISKS THAT ARE OUTSIDE THE CONTROL OF THE SITE. THESE INCLUDE THINGS LIKE AGE, SKIN CONDITION, MEDICAL CONDITIONS, DEVICE USE ERROR AND OFF-LABEL USE. THE WARNING LABELS ON OUR PRODUCT ARE USED TO ADDRESS THESE RISKS AND RELAY THE APPROPRIATE INSTRUCTIONS FOR USE TO OUR CUSTOMERS TO AVOID BURNS, BLISTERS AND SKIN IRRITATIONS. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE (B)(6)2024, VERSION 5.0 AND IT IS RECOMMENDED FOR APPROVAL. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT IDENTIFY BURNS LISTED IN THE HAZARD ANALYSIS RPT-000097160. DURING THE INVESTIGATION OF THIS COMPLAINT RPT-000097160 WAS REVIEWED AND NO FURTHER RISK WAS IDENTIFIED. SINCE THIS COMPLAINT IS NOT JUSTIFIED AND THERE IS NO DEFECT IDENTIFIED, THERE ARE NO CHANGES REQUIRED TO THE RISK DOCUMENTATION AS A RESULT OF THIS INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE EVENT OF THERMAL BURN AS DESCRIBED IN THIS CASE IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, ASSESSED AS ASSOCIATED WITH THE INTENTIONAL DEVICE MISUSE. THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT THERMAL BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE, AND NOT ASSESSABLE FOR INTENTIONAL DEVICE MISUSE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LOWER BACK HIP 8HR PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TRENDS. A 36-MONTH TREND ANALYSIS WILL BE CONDUCTED FOR COMPLAINTS WITH AN UNKNOWN LOT NUMBER SINCE THE DATE OF MANUFACTURE IS NOT KNOWN FOR UNKNOWN LOT NUMBERS. THERE WERE NO COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING RELATED PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE LBH PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    ON (B)(6) 2024, (B)(6). PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING INFORMATION. (B)(6). RECEIVED THE REPORT ON (B)(6) 2024. THE REPORT IS AS FOLLOWS: THIS SERIOUS HEALTH AUTHORITY CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6)2024 FROM A PHARMACIST THROUGH DIAMED (DE4831) (BFARM CASE NUMBER: (B)(4). THIS CASE REPORT CONCERNS A MALE PATIENT (BORN IN 1946, WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH AND EXPIRY DATE: UNKNOWN USED FOR AN UNKNOWN INDICATION. ON (B)(6) 2024, AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT DEVELOPED THERMAL BURN, INTENTIONAL DEVICE MISUSE. ON AN UNKNOWN DATE, A MALE CONSUMER, BORN IN 1946 APPLIED THERMACARE HEATWRAP LOWER BACK AND HIP (BATCH NUMBER UNKNOWN BUT REQUESTED) AND SUFFERED BURNS ON THE LOWER BACK AFTER TWO APPLICATIONS (DAY 1 - 8 HOURS, DAY 2 - 2 HOURS). THE PATIENT HAD USED THE PRODUCT AS INTENDED. HE WORE IT OVER HIS CLOTHING AND DID NOT LIE DOWN DURING APPLICATION. HOWEVER, HE HAD DRIVEN A CAR DURING THE TREATMENT (CONTACT WITH CAR SEAT ON THE BACK). IN ADDITION, THE SAME PLASTER THAT HE WORE ON DAY 1 WAS STILL WARM ENOUGH TO WEAR FOR ANOTHER 2 HOURS THE NEXT DAY. ON DAY 3, THE BURNS APPEARED. THE AREA HAD TO BE TREATED BY A PHYSICIAN WITH A BURN AND WOUND GEL AND DRESSINGS. CONCOMITANT MEDICATION INCLUDED ASS 100 MG IN THE MORNING. NO UNDERLYING DISEASES WERE KNOWN. BFARM CASE NUMBER: (B)(4). OUTCOME: THERMAL BURN: UNKNOWN, INTENTIONAL DEVICE MISUSE: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. (B)(6) MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT THERMAL BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. RECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE, AND NOT ASSESSABLE FOR INTENTIONAL DEVICE MISUSE. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290768 THERMACARE LOWER BACK AND HIP HEAT WRAP HOT OR COLD DISPOSABLE PACK IMD BRIDGES CONSUMER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention