BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE NECK/SHOULDER/WRIST HEAT WRAP

    MDR report key: 24167399 · Received January 23, 2026

    Report

    Report Number
    3007593958-2025-00041
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    February 13, 2026
    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

    ON 29-JAN-2026, ANGELINI S.P.A. PROVIDED ADDITIONAL INFORMATION TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 16-JAN-2026. THE REPORT VERBATIM IS AS FOLLOWS: INVESTIGATION REPORT RECEIVED ON 16-JAN-2026 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF NSW 12HR 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 11 COMPLAINTS FOR NSW 12HR 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 NSW PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. ATTACHED TO THIS RECORD IS A TRENDLINE GRAPH SHOWING THE ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION COMPLAINTS FOR NSW 12HR PRODUCTS OVER THE PAST 36 MONTHS, PROVIDING EVIDENCE THAT THERE HAS BEEN NO INCREASE OVER TIME. 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 WI-000098885 PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 12-JAN-2026 AND IT IS RECOMMENDED FOR APPROVAL. 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 BLISTER AND 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 USE OF THE MEDICAL DEVICE. THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT BURN BLISTER AND 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 (INVALID) LOT NUMBER OF NECK SHOULD WRIST (NSW) 12HR 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 NSW 12HR PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. THE MOST PROBABLE ROOT CAUSE CANNOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING REPORT ON 09-JAN-2026. ANGELINI S.P.A. RECEIVED THE REPORT ON 30-DEC-2025. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6) 2025 FROM A CONSUMER THROUGH (B)(4). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE UNKNOWN, BUT REQUESTED), WHO APPLIED THERMACARE NECK SHOULDER WRIST (BATCH NUMBER UNKNOWN, BUT REQUESTED) BETWEEN CHRISTMAS AND NEW YEAR. THE INDICATION OF USE WAS FOR NECK STIFFNESS. CONCOMITANT MEDICATION(S): UNKNOWN. MEDICAL HISTORY: UNKNOWN ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BURN BLISTER, WHICH WAS CONSIDERED SERIOUS. THE PATIENT HAD NOT YET RECOVERED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN, WHICH WAS CONSIDERED NOT SERIOUS. THE PATIENT HAD NOT YET RECOVERED. A FOLLOW-UP WAS REQUESTED, UNFORTUNATELY, NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. OUTCOME: BURN BLISTER: NOT RECOVERED/NOT RESOLVED. PAIN: NOT RECOVERED/NOT RESOLVED. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT BURN BLISTER AND 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 OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222284 THERMACARE NECK/SHOULDER/WRIST HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention