BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 19767315 · Received July 17, 2024

    Report

    Report Number
    3007593958-2024-00040
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 6, 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

    ON 30-JUL-2024, ANGELINI S.P.A. PROVIDED ADDITIONAL INFORMATION TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 18-JUL-2024. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON 18-JULY-2024 FROM QA DEPARTMENT COMPLAINT NUMBER (B)(4). THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH OF LOWER HIP BACK 8HR 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 (B)(4) COMPLAINTS FOR LOWER BACK HIP 8HR 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 LOWER BACK HIP 8HR 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 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.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    (B)(6) .P.A. PROVIDED THE FOLLOWING REPORT TO BRIDGES CONSUMER HEALTHCARE ON (B)(6) 2024. (B)(6) .P.A. RECEIVED THE INFORMATION ON (B)(6) 2024. THE REPORT IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON (B)(6) 2024 FROM A CONSUMER THROUGH DIAMED (DE4285). THIS CASE REPORT CONCERNS A 45-YEARS-OLD FEMALE PATIENT, WHO APPLIED THERMACARE LOWER BACK AND HIP (LOT NUMBER: UNKNOWN: EXPIRY DATE: UNKNOWN) FOR MUSCLE TIGHTNESS. CONCOMITANT MEDICATION(S): [UNKNOWN] ON (B)(6) 2024, AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT DEVELOPED BURNS SECOND DEGREE AND INTENTIONAL DEVICE MISUSE. A REPORT FROM A FEMALE CONSUMER WAS RECEIVED VIA (B)(6) CUSTOMER SERVICE ON (B)(6) 2024 AND ADDITIONAL INFORMATION ON AGE, ONSET DATE, AND PRODUCT DETAILS WAS OBTAINED ON (B)(6) 2024 VIA EMAIL. ON (B)(6) 2024, THE 45-YEAR-OLD FEMALE CONSUMER APPLIED THERMA CARE HEAT WRAP LBH (BATCH NUMBER UNKNOWN) DUE TO TENSIONS. THE CONSUMER HAS BEEN USING THERMACARE FOR A LONG TIME WITHOUT ANY PROBLEMS. SEVEN HOURS AFTER APPLYING THE PRODUCT AT NIGHT, THE CONSUMER DEVELOPED TWO BURN BLISTERS. OUTCOME: BURNS SECOND DEGREE: UNKNOWN, INTENTIONAL DEVICE MISUSE: UNKNOWN THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. (B)(6) MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP 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 LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/UNLABELED/POSSIBLE. (B)(6) MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP 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 LOWER BACK AND HIP AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE, FOR INTENTIONAL DEVICE MISUSE IT WAS CONSIDERED NOT ASSESSABLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/UNLABELED/POSSIBLE. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142888 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention