BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 20811710 · Received November 29, 2024

    Report

    Report Number
    3007593958-2024-00054
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 20, 2024
    Manufacturer
    [email protected]
    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-DEC-2024, ANGELINI S.P.A. RECEIVED ADDITIONAL INFORMATION AND FORWARDED IT TO (B)(6) ON (B)(6) 2024. IR RECEIVED ON 09-DEC-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 127 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 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. THIS COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE WI-(B)(4) PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 23-OCT-2024, VERSION 5.0 AND IT IS RECOMMENDED FOR APPROVAL. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT IDENTIFY 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 DEFECT IDENTIFIED, THERE ARE NO CHANGES REQUIRED TO THE RISK DOCUMENTATION AS A RESULT OF THIS INVESTIGATION 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 BURNS SECOND DEGREE AND THERMAL BURN 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. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF LOWER BACK HIP 8HR 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 A POTENTIAL TREND. 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 THERMACARE LBH PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    ON 27-NOV-2024, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING REPORT. ANGELINI S.P.A. RECEIVED THE REPORT ON 14-NOV-2024. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(6) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 14/NOV/2024 FROM A PHARMACIST THROUGH DIAMED (DE4754). THIS CASE REPORT CONCERNS A FEMALE PATIENT (AGE NOT REPORTED), WHO APPLIED THERMACARE LOWER BACK AND HIP (BATCH AND EXPIRY DATE: UNKNOWN) USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): UNKNOWN. MEDICAL HISTORY: UNKNOWN. ON (B)(6) 2024, AFTER THERMACARE LOWER BACK AND HIP INITIATION, THE PATIENT EXPERIENCED BURNS SECOND DEGREE, THERMAL BURN. A REPORT FROM A PHARMACIST WAS RECEIVED VIA SERVICE PROVIDER PROPHARMA GROUP ON 14- NOV-2024. IN CALENDAR WEEK 45, A FEMALE CONSUMER APPLIED THERMACARE HEATWRAP LBH (BATCH NUMBER: UNKNOWN BUT REQUESTED) FOR AN UNKNOWN INDICATION. THE CONSUMER SUFFERED FROM A BURN BLISTER AFTER APPLYING THE HEAT WRAP WHICH WAS CAUSED BY ONE OF THE COMPARTMENTS OF THE WRAP. THE CONSUMER THEN CONSULTED A PHYSICIAN BECAUSE OF THE TERRIBLE APPEARANCE AND DEPTH OF THE WOUNDS AND WAS PROPERLY BANDAGED. THE OUTCOME WAS UNKNOWN. OUTCOME: BURNS SECOND DEGREE: UNKNOWN, THERMAL BURN: UNKNOWN. THE ACTION TAKEN TO RESPONSE TO THE EVENT FOR THERMACARE LOWER BACK AND HIP WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE LOWER BACK AND HIP MENTIONS THAT BURNS SECOND DEGREE AND THERMAL BURN 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. THE ANTICIPATED DATE OF THE NEXT REPORT IS 03-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615664 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD [email protected] 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention