BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEAT WRAPS

    MDR report key: 16751999 · Received April 17, 2023

    Report

    Report Number
    3007593958-2023-00020
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 1, 2023
    Report Date
    August 10, 2023
    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 09-AUG-2023, BRIDGES CONSUMER HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM ANGELINI S.P.A. WHO RECEIVED THE INFORMATION ON 01-AUG-2023. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BURN 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 AN INTENTIONAL DEVICE MISUSE. THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BURN COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE HEAT WRAPS AND ADVERSE EVENT IS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNSPECIFIED THERMACARE PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO PRODUCT TYPE, BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TRENDS. THERE IS NOT A TREND IDENTIFIED. THE MOST PROBABLE ROOT CAUSE CANNOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ON 18-MAR-2023, BRIDGES CONSUMER HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM ANGELINI S.P.A. WHO RECEIVED THE INFORMATION ON 10-MAY-2023. THE REPORT VERBATIM IS AS FOLLOWS: FOLLOW-UP INFORMATION RECEIVED ON 10-MAY-2023 FROM QA DEPARTMENT. COMPLAINT NUMBER((B)(4)): THIS INVESTIGATION WAS CONDUCTED FOR AN UNSPECIFIED THERMACARE PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO PRODUCT TYPE, BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE, A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED FOR COMPLAINTS WITH AN UNKNOWN LOT NUMBER SINCE THE DATE OF MANUFACTURE IS NOT KNOWN FOR UNKNOWN LOT NUMBERS. THE TWD SEARCH RETURNED A TOTAL OF 31 COMPLAINTS FOR THE NONSPECIFIC THERMACARE PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS FOR ALL ADVERSE EVENTS (INCLUDING BURNS). THERE WERE NO COMPLAINTS CONFIRMED TO HAVE A MANUFACTURING RELATED PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THIS SEARCH INCLUDES ALL ADVERSE EVENTS, NOT ONLY THOSE FOR BURNS, THEREFORE IT IS NOT INTENDED TO BE USED FOR DETERMINING SIMILAR INCIDENTS AS PER MIR HELP TEXT OF THE COMMISSION. BASED ON THIS TWD SEARCH, THE DATA DID NOT SHOW AN INCREASE OVER TIME. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE NONSPECIFIC PRODUCT. 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 A BURN LISTED 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. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). DURING THE INVESTIGATION OF THIS COMPLAINT RPT-000097160 WAS REVIEWED AND NO FURTHER RISK WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE EXPECTED DATE OF THE NEXT REPORT IS 23-MAY-2023.

    Description of Event or Problem · 0

    ON 09-AUG-2023, BRIDGES CONSUMER HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM ANGELINI S.P.A. WHO RECEIVED THE INFORMATION ON 01-AUG-2023. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BURN 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 BURN IS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE FOLLOW-UP INFORMATION WAS RECEIVED ON 01-AUG-2023 . THE 64-YEARS OLD FEMALE PATIENT STATED THAT THE INDICATION FOR USE WERE PROBLEMS WITH HER SCIATIC NERVE. SHE HAD USED THE PRODUCT IN THE BEGINNING ON (B)(6) 2023 FOR APPROX. 3 HOURS. SHE HAD APPLIED THE HEAT WRAP DIRECTLY ON HER SKIN. THE INJURY IS STILL NOT HEALED UNTIL TODAY. FURTHER INFORMATION REGARDING BATCH NO. IS NOT AVAILABLE AS THE PACKAGE WAS ALREADY DISCARDED. ANGELINI MEDICAL ASSESSMENT: THE INFORMATION PROVIDED IN THIS FOLLOW UP DOES CHANGE THE PREVIOUS ASSESSMENT. THE PI OF THERMACARE HEAT WRAPS DOES NOT MENTION THAT INTENTIONAL DEVICE MISUSE COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE NOT APPLICABLE FOR THIS EVENT. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE HEAT WRAPS AND INTENTIONAL DEVICE MISUSE IS CONSIDERED AS NOT ASSESSABLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/UNLABELED/POSSIBLE.

    Description of Event or Problem · 0

    ANGELINI S.P.A. RECEIVED THE SPONTANEOUS REPORT FROM ANGELINI S.P.A. ON 13-APR-2023. ANGELINI S.P.A. RECEIVED THE REPORT ON 03-APR-2023. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 03/APR/2023 FROM A CONSUMER/OTHER NON HEALTH PROFESSIONAL THROUGH DIAMED ((B)(4)). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED THERMACARE HEAT WRAPS (BATCH NUMBER AND EXPIRY DATE UNKNOWN) USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT REPORTED. ON 03/APR/2023, AFTER THERMACARE HEAT WRAPS INITIATION, THE PATIENT EXPERIENCED BURN AFTER THE USE OF THE HEAT WRAPS ABOUT FOUR WEEKS AGO, WHICH HAS STILL NOT BEEN CURED UNTIL NOW. OUTCOME: BURN: NOT RECOVERED/NOT RESOLVED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEAT WRAPS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827398 THERMACARE HEAT WRAPS HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention