BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 17977490 · Received October 20, 2023

    Report

    Report Number
    3007593958-2023-00064
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 30, 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

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP RECEIVED ON 15-OCT-2023 REGARDING BATCH NUMBER: (GA0509.) WAS MERGED WITH THE FOLLOW-UP INFORMATION RECEIVED ON 18-OCT-2023 FROM QA (PRODUCT COMPLAINT: (B)(4). BATCH#: GA0509, BATCH CODE/SKU#: F00573301023W, PRODUCT COUNT: 2 COUNT, DATE OF MANUFACTURE: 15-JUN-2022 TO 19-JUN-2022, EXPIRY DATE: 05-31-2025, QUANTITY RELEASED: (B)(4) CARTONS. A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED. THE TREND ANALYSIS RETURNED A TOTAL OF 123 COMPLAINTS FOR LOWER BACK/HIP (LBH) HEAT WRAP 8 HR PRODUCTS DURING THE PERIOD 10-04-2020 TO 10-04-2023 FOR THE CLASS/SUBCLASS. THE SEARCH DESCRIBED IN THIS INVESTIGATION SUMMARY TAKES INTO CONSIDERATION ALL ADVERSE EVENTS. THIS SEARCH WAS NOT SPECIFIC TO BURNS ONLY. NONE OF THE COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. BASED ON THIS TREND ANALYSIS, 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 LOWER BACK HIP 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/BLISTER LISTED IN THE HAZARD ANALYSIS (B)(4). THERE ARE MITIGATION'S 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. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE 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 IDENTIFIED DEFECT, THERE IS NO CHANGE NEEDED TO THE RISK DOCUMENTATION AS A RESULT OF THIS INVESTIGATION. CRITICALITY MINOR. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BURN THERMAL 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 THE INTENTIONAL DEVICE MISUSE. THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT THERMAL BURN COULD BE ADVERSE EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE EVENT IS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE. BATCH GA0509 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THE DEVICE HISTORY RECORD, MANUFACTURING ELECTRONIC SYSTEM RECORDS, RETAIN SAMPLES, THERMAL RESULTS, RAW MATERIALS AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED DURING THE PRODUCTION OF THE BATCH. THE VISUAL INSPECTION OF A RETAIN SAMPLE INCLUDED ONE CARTON AND THE TWO POUCHED WRAPS INSIDE AND SHOWS NO OBVIOUS DEFECTS TO CARTON OR POUCHED WRAPS. THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND FOR THE LOT AND SUBCLASS. A TREND DOES NOT EXIST FOR THIS BATCH. THE REVIEW OF THE MANUFACTURING ATTRIBUTES AND VARIABLES QUALITY CHECKS ASSOCIATED WITH THIS BATCH INDICATES THAT ALL REQUIRED IN PROCESSING INSPECTIONS WERE PERFORMED AND ALL INSPECTION CRITERIA WERE MET. THERMAL DATA FOR THE BATCH SHOWS ALL WRAPS MET THE REQUIRED WRAP BATCH AVERAGE TEMPERATURES. THERE WERE NO WRAP ATTRIBUTE OR VARIABLE DEFECTS RECORDED FOR THE BATCH. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2023-032174 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 04-OCT-2023 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH DIAMED (DE3210). THIS CASE REPORT CONCERNS A 75-YEARS-OLD FEMALE PATIENT, WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH NUMBER WAS UNKNOWN) FOR UNKNOWN INDICATION, CONCOMITANT MEDICATIONS TO TREAT AE: DISINFECTANT; MEDIGEL, TYROSUR WOUND HEALING GEL, COMPRESSE, BAND-AIDS. MEDICAL HISTORY WAS UNKNOWN. ON (B)(6) 2023, AFTER THERMACARE HEAT WRAPS FOR LOWER BACK INITIATION, THE PATIENT EXPERIENCED THERMAL BURN, INTENTIONAL DEVICE MISUSE. IN (B)(6) 2023 (AT SOME POINT IN CALENDAR WEEK 39), THE CONSUMER'S 75-YEAR-OLD MOTHER NOTICED BURNS AFTER APPLYING THE HEAT WRAP FOR APPROXIMATELY 8 HOURS. THE HEAT WRAP WAS APPLIED DIRECTLY ONTO THE SKIN. THE AILMENT WAS STILL ONGOING AND WAS TREATED BY DISINFECTING THE AREA IN THE MORNING AND EVENING AND APPLYING MEDIGEL AND TYROSUR WOUND HEALING GEL. IN ADDITION, THE AREA WAS COVERED WITH COMPRESSES AND BAND AIDS FOR PROTECTION. FURTHER INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. OUTCOME: THERMAL BURN: NOT RECOVERED/NOT RESOLVED, INTENTIONAL DEVICE MISUSE : NOT RECOVERED/NOT RESOLVED. THE ACTION TAKEN FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. (B)(6) MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT THERMAL BURN COULD BE ADVERSE AN EVENT OF THIS MEDICAL DEVICE, WHEREAS IT DOES NOT MENTION INTENTIONAL DEVICE MISUSE. DE-CHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENTS-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE, WHEREAS FOR PRODUCT QUALITY COMPLAINT IT WAS CONSIDERED NOT ASSESSABLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS 23-NOV-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984248 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention