BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE NECK/SHOULDER/WRIST

    MDR report key: 21285062 · Received January 31, 2025

    Report

    Report Number
    3007593958-2025-00001
    Event Type
    Injury
    Date Received
    January 31, 2025
    Report Date
    January 31, 2025
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRIDGES CONSUMER HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM ANGELINI S.P.A. ON 31-JAN-2025. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 21-JAN-2025. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON 21 JAN 2025 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 48 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 (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. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 31 DEC-2024, VERSION 6.0 AND IT IS RECOMMENDED FOR APPROVAL. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT IDENTIFY BURNS 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 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 BURNS THIRD DEGREE, BURNS SECOND DEGREE, BURN BLISTER, REDNESS, MEDICAL DEVICE SITE PAIN AND THE CONSEQUENT NECROSIS 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 NECK SHOULDER WRIST 8 HOUR MENTIONS THAT BURNS THIRD DEGREE, BURNS SECOND DEGREE BURN BLISTER, REDNESS, MEDICAL DEVICE SITE PAIN AND THE CONSEQUENT NECROSIS, 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 8 HOUR 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 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 17-JAN-2025, ANGELINI S.P.A. FORWARDED THE FOLLOWING REPORT TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE REPORT ON 08-JAN-2025. THE REPORT VERBATIM IS AS FOLLOWS. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 08-JAN-2025 FROM A PHYSICIAN THROUGH DIAMED (DE4978). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED THERMACARE NECK SHOULDER WRIST 8 HOUR (BATCH: UNKNOWN: EXPIRY DATE: UNKNOWN) NECK DISCOMFORT. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN. ON UNKNOWN DATE, AFTER THERMACARE NECK SHOULDER WRIST 8-HOUR INITIATION, THE PATIENT DEVELOPED NECROSIS, MEDICAL DEVICE SITE PAIN, BURN BLISTER, REDNESS, BURNS SECOND DEGREE, BURNS THIRD DEGREE. ONE WEEK AGO (IN CALENDAR WEEK ONE) BEFORE THE PATIENT PRESENTED TO A PHYSICIAN WITH NECROSIS IN THE NECK AREA. THE PATIENT APPLIED THE HEAT WRAP FOR 4 HOURS FOR NECK PAIN AND REMOVED IT AGAIN WHEN SHE EXPERIENCED MEDICAL DEVICE SITE PAIN, BURN BLISTER AND REDNESS. THE PATIENT WAS TREATED WITH A BURN OINTMENT. OUTCOME: NECROSIS: UNKNOWN, MEDICAL DEVICE SITE PAIN: UNKNOWN, BURN BLISTER: UNKNOWN, REDNESS: UNKNOWN, BURNS SECOND DEGREE: UNKNOWN, BURNS THIRD DEGREE: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE NECK SHOULDER WRIST 8 HOUR WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE NECK SHOULDER WRIST 8 HOUR MENTIONS THAT BURNS THIRD DEGREE, BURNS SECOND DEGREE BURN BLISTER, REDNESS, MEDICAL DEVICE SITE PAIN AND THE CONSEQUENT NECROSIS, 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 8 HOUR AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519693 THERMACARE NECK/SHOULDER/WRIST HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention