BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP HEAT WRAP

    MDR report key: 22341977 · Received June 26, 2025

    Report

    Report Number
    3007593958-2025-00022
    Event Type
    Injury
    Date Received
    June 26, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ON 03-JUL-2025, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE WITH THE FOLLOWING REPORT. ANGELINI S.P.A. RECEIVED THE REPORT ON 23-JUN-2025. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON 23/06/2025 FROM QA DEPARTEMNT. COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF 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 RECORDS SEARCH RETURNED A TOTAL OF 114 COMPLAINTS FOR LBH 8HR PRODUCT DURING THIS TIME PERIOD. THE SEARCH DESCRIBED IN THIS INVESTIGATION SUMMARY TAKES INTO CONSIDERATION ALL ADVERSE EVENTS. 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. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE SKIN BURNS IN THE HAZARD ANALYSIS ((B)(4)). 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. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS ((B)(4)). DURING THE INVESTIGATION OF THIS COMPLAINT (B)(4) WAS REVIEWED AND NO FURTHER RISK WAS IDENTIFIED. SINCE THIS COMPLAINT IS NOT JUSTIFIED AND THERE IS NO IDENTIFIED DEFECT, THERE IS NO CHANGE NEEDED TO THE RISK DOCUMENTATION AS A RESULT OF THIS INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BURN AND BLISTER 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 USE OF THE MEDICAL DEVICE. THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURN AND BLISTER COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. 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 EVENTS WAS CONSIDERED AS POSSIBLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LBH 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.

    Description of Event or Problem · 0

    ON 20-JUN-2025, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE WITH THE FOLLOWING REPORT. ANGELINI S.P.A. RECEIVED THE REPORT ON 11-JUN-225. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER: (B)(4) (LOCAL NUMBER: (B)(4) IS AN INITIAL REPORT FROM SPAIN RECEIVED ON 11/JUNE/2025 FROM A PHARMACY THROUGH AN ANGELINI SPAIN. THIS CASE REPORT CONCERNS A FEMALE CONSUMER (AGE NOT REPORTED) WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH NUMBER UNKNOWN; EXPIRY DATE: UNKNOWN) USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION: UNKNOWN. MEDICAL HISTORY: UNKNOWN. ON AN UNKNOWN DATE, AFTER THERMACARE LOWER BACK AND HIP APPLICATION THE PATIENT EXPERIENCED BURNS (BURN) AND BLISTERS (BLISTER). THE PHARMACY STATED THAT THE CUSTOMER USUALLY USES THERMACARE AND SHE HAS USED IT CORRECTLY, AND THAT WHEN SHE USED IT THIS TIME SHE GOT BURNS AND BLISTERS IN THE APPLICATION AREA. THEY DID NOT HAVE THE BATCH OF THE PRODUCT NOR WERE THEY ABLE TO TELL US THE AGE OF THE CUSTOMER. OUTCOME: BURN: UNKNOWN; BLISTER: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURN AND BLISTER COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. 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 EVENTS WERE CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS 31-JUL-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807630 THERMACARE LOWER BACK & HIP HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention