BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 20685153 · Received November 14, 2024

    Report

    Report Number
    3007593958-2024-00051
    Event Type
    Injury
    Date Received
    November 14, 2024
    Report Date
    November 12, 2024
    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

    INVESTIGATION REPORT RECEIVED ON 29/10/2024 FROM QA DEPARTMENT. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 23-OCT-2024 AND IT IS RECOMMENDED FOR APPROVAL. A 36-MONTH TREND ANALYSIS HAS BEEN CONDUCTED. THE TREND ANALYSIS RETURNED A TOTAL OF (B)(4) COMPLAINTS FOR LBH 8 HOUR PRODUCTS DURING THE PERIOD 10-21-2021 TO 10-21-2024 FOR THE CLASS/SUBCLASS. NONE OF THE COMPLAINTS WERE CONFIRMED TO HAVE A MANUFACTURING PROCESS ROOT CAUSE FOR A COMPLAINT OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE PPM FOR THIS COMPLAINT IS 1.72 PPM; WHICH IS WITHIN THE CONTROL LIMIT FOR THIS SUBCLASS AND PRODUCT TYPE. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THERMACARE LBH 8HR PRODUCTS. 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 - (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. 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. ALL MATERIALS USED IN THE PRODUCTION OF THIS BATCH WERE INSPECTED AND RELEASED BY QUALITY CONTROL BEFORE BEING RELEASED FOR USE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. DURING THE INVESTIGATION OF THIS COMPLAINT (B)(4) - HAZARD ANALYSIS THERMACARE HEAT WRAP PRODUCT: 8 AND 12HR 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 MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, THERMAL BURN, SKIN IRRITATION, 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 DEVICE USE. THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, THERMAL BURN, SKIN IRRITATION, PAIN RELATED TO THE BURNS 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 LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENTS WAS CONSIDERED AS POSSIBLE. BATCH GA0511 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. INSPECTION OF RETAIN SAMPLES. NO RETAIN EVALUATION IS REQUIRED FOR THIS COMPLAINT, AS NO DEFECT WAS REPORTED. A VISUAL INSPECTION OF THE PRODUCT WOULD NOT BE BENEFICIAL AS A CONSUMER EXPERIENCING A BURN CANNOT BE DETECTED BY REVIEWING THE WRAP. THE COMPLAINT WAS EVALUATED TO IDENTIFY A POTENTIAL TREND FOR THE BATCH AND SUBCLASS. THE EVALUATION OF THE BATCH HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS BATCH. 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. THE BATCH DEVICE HISTORY RECORD FOR THIS BATCH CONCLUDES ALL RELEASE REQUIREMENTS WERE MET. 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. THE MOST PROBABLE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    ANGELINI S.P.A. RECEIVED THE FOLLOWING REPORT ON 21-OCT-2024 AND PROVIDED THE REPORT TO BRIDGES CONSUMER HEALTHCARE ON 29-OCT-2024. ANGELINI S.P.A. RECEIVED ADDITIONAL INFORMATION ON 29-OCT-2024 AND PROVIDED THE INFORMATION TO BRIDGES CONSUMER HEALTHCARE ON 11-NOV-2024 WHICH WAS INCORPORATED INTO THIS REPORT. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 21/OCT/2024 FROM A CONSUMER THROUGH DIAMED (DE4632). THIS CASE REPORT CONCERNS A 38-YEARS-OLD FEMALE PATIENT, WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH: GA0511; EXPIRY DATE: UNKNOWN) FOR BACK PAIN. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN. ON (B)(6) 2024, AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT DEVELOPED MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, THERMAL BURN, SKIN IRRITATION, PAIN. A REPORT FROM A CONSUMER WAS RECEIVED VIA ANGELINI CUSTOMER SERVICE ON 21-OCT-2024 AND ADDITIONAL INFORMATION WAS RECEIVED AS RESPONSE TO FOLLOW-UP REQUEST ON 21-OCT-2024 AND 22-OCT-2024. ON (B)(6) 2024, A 38-YEAR-OLD FEMALE CONSUMER APPLIED A THERMACARE HEAT WRAP LBH FOR APPROXIMATELY 3 HOURS (5-8 PM). INDICATION FOR USE WAS BACK PAIN IN THE LUMBAR REGION. THE CONSUMER SUFFERED BURN BLISTERS ON HER BACK. THE CONSUMER CONSULTED A GENERAL PHYSICIAN WHO RECOMMENDED TO COVER THE BURN BLISTERS WITH A PLASTER. DUE TO THE SEVERE SKIN IRRITATION, THIS WAS VERY UNCOMFORTABLE, AND THE CONSUMER TREATED THE SKIN WITH TYROSUR CARE EXPERT WOUND GEL (ALLANTOIN, DEXPANTHENOL, CETYLPYRIDINIUM CHLORID, CARBOMER). ON (B)(6) 2024, THE CONSUMER STILL SUFFERED FROM SEVERE PAIN AS THE AFFECTED AREA KEPT TEARING OPEN WHEN THE CONSUMER MOVED. OUTCOME: MEDICAL DEVICE SITE BURN: RECOVERING/RESOLVING, BURNS SECOND DEGREE : RECOVERING/RESOLVING, THERMAL BURN : RECOVERING/RESOLVING, SKIN IRRITATION : RECOVERING/ RESOLVING, PAIN : RECOVERING/RESOLVING. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, THERMAL BURN, SKIN IRRITATION, PAIN RELATED TO THE BURNS 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 LOWER BACK AND HIP 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
    2232273 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE GA0511 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention