THERMACARE NECK/SHOULDER/WRIST HEAT WRAP
Report
- Report Number
- 3007593958-2025-00010
- Event Type
- Injury
- Date Received
- March 21, 2025
- Date of Event
- February 23, 2025
- Report Date
- April 30, 2025
- Manufacturer
- BRIDGES CONSUMER HEALTHCARE
- Product Code
- IMD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.
ON 15-APR-2025, ANGELINI S.P.A PROVIDED BRIDGES CONSUMER HEALTHCARE ADDITIONAL INFORMATION. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 07-APR-2025. IR RECEIVED ON 07-APR-2025 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF ALL NECK SHOULDER WRIST (NSW) PRODUCT (BOTH 8 AND 12 HOUR). 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 (B)(4) COMPLAINTS FOR ALL NECK SHOULDER WRIST 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 NECK SHOULDER WRIST (NSW) PRODUCT (BOTH 8 AND 12 HOUR). 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 (B)(6) 2024 AND IT IS RECOMMENDED FOR APPROVAL. IMPACT ANALYSIS: 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 BURNS SECOND DEGREE 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 INTENTIONAL DEVICE MISUSE. THE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT BURNS SECOND DEGREE COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. 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 EVENT WAS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE. 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 NECK SHOULDER WRIST (UNKNOWN 8 OR 12 HOUR) PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE.
ANGELINI S.P.A. PROVIDED THE FOLLOWING INFORMATION TO BRIDGES CONSUMER HEALTHCARE ON 13-MAR-2025. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 28-FEB-2025. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER'S CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM FRANCE RECEIVED ON 28-FEB-2025 FROM A CONSUMER VIA COOPER (MV2025006). THIS CASE REPORT CONCERN A PATIENT (AGE AND GENDER NOT REPORTED) WHO APPLIED THERMACARE NECK SHOULDER WRIST (LOT: UNKNOWN; EXPIRATION DATE: UNKNOWN) FOR CONTRACTURE. MEDICAL HISTORY: UNKNOWN. CONCOMITANTS: UNKNOWN. ON (B)(6) 2025, AFTER THE START OF THERMACARE NECK SHOULDER WRIST, THE PATIENT DEVELOPED BURNS SECOND DEGREE, INTENTIONAL DEVICE MISUSE. THE PATIENT STATES THAT DUE TO A CERVICAL CONTRACTURE, THE PATIENT PURCHASED THERMACARE HEATING PATCHES FOR THEIR NECK AT THE PHARMACY. THE PATIENT APPLIED THE PATCH SUNDAY NIGHT AROUND 9:30-10:00 P.M. TO SLEEP WITH IT AND KEPT IT ON UNTIL MONDAY AT 12:30 P.M. THE PATIENT DID NOT EXCEED 16 HOURS. THE PATIENT AT THE END OF THIS PERIOD HAD A SUPERFICIAL SECOND-DEGREE BURN, AS CONFIRMED BY A PHYSICIAN. OUTCOME: BURNS SECOND DEGREE: UNKNOWN, INTENTIONAL DEVICE MISUSE: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE NECK SHOULDER WRIST WAS UNKNOWN.
ANGELINI S.P.A. PROVIDED THE FOLLOWING INFORMATION TO BRIDGES CONSUMER HEALTHCARE ON 13-MAR-2025. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 28-FEB-2025. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER'S CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM FRANCE RECEIVED ON 28-FEB-2025 FROM A CONSUMER VIA COOPER (B)(4). THIS CASE REPORT CONCERN A PATIENT (AGE AND GENDER NOT REPORTED) WHO APPLIED THERMACARE NECK SHOULDER WRIST (LOT: UNKNOWN; EXPIRATION DATE: UNKNOWN) FOR CONTRACTURE. MEDICAL HISTORY: UNKNOWN. CONCOMITANTS: UNKNOWN. ON (B)(6) 2025, AFTER THE START OF THERMACARE NECK SHOULDER WRIST, THE PATIENT DEVELOPED BURNS SECOND DEGREE, INTENTIONAL DEVICE MISUSE THE PATIENT STATES THAT DUE TO A CERVICAL CONTRACTURE, THE PATIENT PURCHASED THERMACARE HEATING PATCHES FOR THEIR NECK AT THE PHARMACY. THE PATIENT APPLIED THE PATCH SUNDAY NIGHT AROUND 9:30-10:00 P.M. TO SLEEP WITH IT AND KEPT IT ON UNTIL MONDAY AT 12:30 P.M. THE PATIENT DID NOT EXCEED 16 HOURS. THE PATIENT AT THE END OF THIS PERIOD HAD A SUPERFICIAL SECOND-DEGREE BURN, AS CONFIRMED BY A PHYSICIAN. OUTCOME: BURNS SECOND DEGREE: UNKNOWN, INTENTIONAL DEVICE MISUSE: UNKNOWN. 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 BURNS SECOND DEGREE COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. 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 EVENT WAS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 901094 | THERMACARE NECK/SHOULDER/WRIST HEAT WRAP | HOT OR COLD DISPOSABLE PACK. | IMD | BRIDGES CONSUMER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |