BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEAT WRAP

    MDR report key: 21799220 · Received April 8, 2025

    Report

    Report Number
    3007593958-2025-00012
    Event Type
    Injury
    Date Received
    April 8, 2025
    Report Date
    May 19, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ON 30-APR-2025, THE FOLLOWING INFORMATION WAS PROVIDED TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 22-APR-2025. THE VERBATIM OF THE REPORT IS AS FOLLOWS: A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED. THE TREND ANALYSIS RETURNED A TOTAL OF NINE (9) COMPLAINTS FOR FLEX USE XL PRODUCTS DURING THE PERIOD 03/12/2022 THROUGH 03/12/2025 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 1.55 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 FLEX XL USE PRODUCT. THE MOST PROBABLE ROOT CAUSE IS INTENTIONAL DEVICE MISUSE. THE CONSUMER STATES SHE IS 78 YEARS OLD AND "I HAVE APPLIED DIRECTLY TO THE SKIN AS USUAL (NEVER HAD ANY PROBLEMS)". THE THERMACARE LABELING AND INSTRUCTIONS FOR USE PROVIDE GUIDANCE FOR THE CUSTOMER TO PREVENT INJURY DURING USE. THE PACKAGING INSTRUCTION WARNS THE CONSUMER, IF 55 AND OLDER, WEAR OVER A LAYER OF CLOTHING (OR CLOTH), NOT DIRECTLY AGAINST YOUR SKIN. 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 WI-000098885 PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 31-DEC-2024 AND IT IS RECOMMENDED FOR APPROVAL. IMPACT ANALYSIS: THERE ARE PRE-IDENTIFIED RISK FACTORS THAT IDENTIFY INTENTIONAL DEVICE MISUSE 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. IMPACT ANALYSIS: THERE ARE PRE-IDENTIFIED RISK FACTORS THAT IDENTIFY INTENTIONAL DEVICE MISUSE 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 BLISTER AND THE RELATED ITCHING, SKIN OOZING AS OTHER CHANGES IN THE SKIN 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 HEAT WRAPS MENTIONS THAT BLISTER COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE HEAT WRAPS AND THE EVENT IS CONSIDERED AS POSSIBLE. PARENT BATCH GA0535 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. VISUAL INSPECTION OF THE PRODUCT WOULD NOT BE BENEFICIAL AS A CONSUMER EXPERIENCING A BURN/BLISTER CAN'T BE DETECTED BY REVIEWING THE WRAP. THERMAL TESTING IS PERFORMED ON EACH BATCH BEFORE IT IS RELEASED INTO THE MARKETS. 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 FLEX USE XL PRODUCT. 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 IS INTENTIONAL DEVICE MISUSE.

    Description of Event or Problem · 0

    ANGELINI S.P.A. PROVIDED THE INFORMATION TO BRIDGES CONSUMER HEALTHCARE ON (B)(6)2025. ANGELINI S.P.A. RECEIVED THE INFORMATION ON (B)(6)2025. THE REPORT VERBATIM IS AS FOLLOWS: THIS SPONTANEOUS, SERIOUS INCIDENT, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6)2025 FROM A CONSUMER THROUGH A DIAMED (B)(4). THE CASE IS LINKED TO (B)(4) (SAME PATIENT). THIS CASE CONCERNS A 78-YEAR-OLD FEMALE PATIENT WHO APPLIED THERMACARE HEAT WRAPS (BATCH NUMBER GA0535A, EXPIRY DATE: 2025-03, PZN-13167262) FOR PAIN. CONCOMITANT MEDICATIONS: UNKNOWN. MEDICAL HISTORY: UNKNOWN. ON UNKNOWN DATE, THE CONSUMER APPLIED THERMACARE HEAT WRAPS INITIATION, THE PATIENT EXPERIENCED BLISTER, INTENTIONAL DEVICE MISUSE, ITCHING, SKIN OOZING. THE CONSUMER STATED THAT SHE USED THERMACARE DIRECTLY ON THE SKIN (INTENTIONAL DEVICE MISUSE) AND STATED THAT SHE NEVER HAD ANY PROBLEMS WITH THE APPLICATION LIKE THIS. CONSEQUENTLY, THE CONSUMER IS ENQUIRING WHETHER THE FORMULA FOR THERMACARE WAS CHANGED AND IF ARNICA WAS ADDED, THE QUESTION WAS REGISTERED UNDER (B)(4). OUTCOME: BLISTER: UNKNOWN, ITCHING: UNKNOWN, SKIN OOZING: UNKNOWN, INTENTIONAL DEVICE MISUSE: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEAT WRAPS WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BLISTER AND THE RELATED ITCHING, SKIN OOZING AS OTHER CHANGES IN THE SKIN 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 HEAT WRAPS AND THE EVENTS IS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740735 THERMACARE HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE GA0535A 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention