BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEAT WRAP

    MDR report key: 22566763 · Received July 22, 2025

    Report

    Report Number
    3007593958-2025-00027
    Event Type
    Injury
    Date Received
    July 22, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ON 24-JUL-2025, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING REPORT. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 14-JUL-2025. THE REPORT VERBATIM IS AS FOLLOWS: A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED. THE TREND ANALYSIS RETURNED A TOTAL OF 113 COMPLAINTS FOR THERMACARE LBH PRODUCTS DURING THE PERIOD 07-01-2022 TO 07-01-2025 FOR THE DEFECT 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 1.55 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 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 A BURN LISTED 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. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. ALL MATERIALS USED IN THE PRODUCTION OF THIS BATCH WERE INSPECTED AND RELEASED BY QUALITY CONTROL BEFORE BEING RELEASED FOR USE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 30-MAY-2025 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 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 HEAT WRAPS MENTIONS THAT BURN BLISTER COULD BE AN ADVERSE EVENT 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 HEAT WRAPS AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE. BATCH GA1167 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THE DEVICE HISTORY RECORD, MANUFACTURING ELECTRONIC SYSTEM RECORDS, RETAIN SAMPLES, THERMAL RESULTS, RAW MATERIALS AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE PRODUCTION OF THE BATCH. NO RETAIN EVALUATION IS REQUIRED FOR THIS COMPLAINT, AS NO DEFECT WAS REPORTED. A VISUAL INSPECTION OF THE PRODUCT WOULD NOT BE BENEFICIAL AS A CONSUMER EXPERIENCING A BURN CAN'T BE DETECTED BY REVIEWING THE WRAP. THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND FOR THE BATCH AND SUBCLASS. THE EVALUATION OF THE BATCH HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND FOR THE SUBCLASS AND PRODUCT TYPE. 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. THE BATCH DEVICE HISTORY RECORD FOR THIS BATCH CONCLUDES THAT ALL RELEASE REQUIREMENTS WERE MET. THE REVIEW OF THE MANUFACTURING ATTRIBUTES AND VARIABLES QUALITY CHECKS ASSOCIATED WITH THIS BATCH INDICATES THAT ALL REQUIRED IN PROCESSING INSPECTIONS WERE PERFORMED AND ALL INSPECTION CRITERIA WERE MET. THERMAL DATA FOR THE BATCH SHOWS ALL WRAPS MET THE REQUIRED WRAP BATCH AVERAGE TEMPERATURES. THE MOST PROBABLE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING REPORT ON 14-JUL-2025. ANGELIN S.P.A. RECEIVED THE REPORT ON 01-JUL-2025. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS, SPONTANEOUS INCIDENT, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM AUSTRIA (B)(4) RECEIVED ON 01-JUL-2025 FROM A PHARMACIST VIA FIELD FORCE. THIS CASE CONCERNS AN ADULT FEMALE PATIENT (AGE APPROX. 40 YEARS) WHO USED THERMACARE HEAT WRAPS FOR AN UNKNOWN INDICATION AND EXPERIENCED BURN BLISTERS (BATCH NUMBER GA1167). THE PATCH WAS PLACED WAS PLACED DIRECTLY TO THE SKIN. UNFORTUNATELY, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. SUSPECT: THERMACARE HEAT WRAPS. OUTCOME: BURN BLISTER: UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BURN BLISTER COULD BE AN ADVERSE EVENT 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 HEAT WRAPS AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS 20-AUG-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712627 THERMACARE HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention