BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE NECK/SHOULDER/WRIST

    MDR report key: 20979902 · Received December 19, 2024

    Report

    Report Number
    3007593958-2024-00057
    Event Type
    Injury
    Date Received
    December 19, 2024
    Report Date
    December 23, 2024
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANGELINI S.P.A. RECEIVED ADDITIONAL INFORMATION ON 18-DEC-2024 AND PROVIDED THE INFORMATION TO BRIDGES CONSUMER HEALTHCARE ON 23-DEC-2024. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON 18-DEC-2024 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF NECK SHOULDER WRIST (NSW) UNKNOWN 8HR OR 12-HOUR 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 47 COMPLAINTS FOR ALL NECK SHOULDER WRIST (NSW) PRODUCTS 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 ALL NECK SHOULDER WRIST 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 (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 WI-000098885 PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 23-OCT-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 AND THE RELATED PAIN 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 DEVICE USE. THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT THERMAL BURN AND THE RELATED PAIN 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 NECK SHOULDER WRIST AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF NECK SHOULDER WRIST (UNKNOWN 8 OR 12 HOUR) 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 A 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 NSW 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 18-DEC-2024, ANGELINI S.P.A. FORWARDED THE FOLLOWING INFORMATION TO BRIDGES CONSUMER HEALTHCARE. ON 12-DEC-2024, ANGELINI S.P.A. RECEIVED THE FOLLOWING INFORMATION. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 12-DEC-2024 FROM A CONSUMER THROUGH A DIAMED. THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED) WHO APPLIED THERMACARE NECK SHOULDER WRIST (BATCH NUMBER UNKNOWN BUT REQUESTED AND EXPIRY DATE UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN. ON UNKNOWN DATE AFTER THERMACARE NECK SHOULDER WRIST INITIATION, THE PATIENT EXPERIENCED THERMAL BURN AND PAIN. THE INDICATION FOR USE WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER APPLIED THE HEAT WRAP ACCORDING TO THE INSTRUCTIONS FOR USE BUT NEVERTHELESS, SHE EXPERIENCED A BURN WHICH WAS VERY PAINFUL AND HEALED VERY SLOWLY. OUTCOME: THERMAL BURN: RECOVERED/RESOLVED, PAIN : RECOVERED/RESOLVED. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE NECK SHOULDER WRIST WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT THERMAL BURN AND THE RELATED PAIN 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 NECK SHOULDER WRIST AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083263 THERMACARE NECK/SHOULDER/WRIST HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention