BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP

    MDR report key: 20646081 · Received November 8, 2024

    Report

    Report Number
    3007593958-2024-00050
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 15, 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 11-NOV-2024, ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FLOWING INFORMATION WHICH THEY RECEIVED ON 29-OCT-2024. THE REPORT IS AS FOLLOWS: IR RECEIVED ON 29 OCT 2024, FROM QA DEPARTEMENT 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 125 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-000098885 PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 23-OCT-2024, VERSION 5.0 AND IT IS RECOMMENDED FOR APPROVAL. THE INVESTIGATION WAS REOPENED BY (B)(6) ON 29-OCT-2024 TO ATTACH CIOMS 2024 036154(0) AND ADD REFERENCE TO THE CIOMS IN MEDICAL REVIEW NEEDED AND REGULATORY REPORTING NEEDED. NO OTHER CHANGES WERE MADE TO THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    THE FOLLOWING REPORT WAS FORWARDED BY ANGELINI S.P.A. TO BRIDGES CONSUMER HEALTHCARE ON 29-OCT-2024. ANGELINI S.P.A. RECEIVED THE FOLLOWING REPORT ON 20-OCT-2024. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER (B)(4) IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 20/OCT/2024 FROM A CONSUMER THROUGH DIAMED (DE4626). THIS CASE REPORT CONCERNS A 44-YEARS-OLD FEMALE PATIENT, WHO APPLIED THERMACARE LOWER BACK AND HIP (LBH) HEAT WRAP (BATCH AND EXPIRY DATE: UNKNOWN) USED FOR BACK PAIN. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN. ON (B)(6) 2024, AFTER THERMACARE HEAT WRAP LBH INITIATION, THE PATIENT DEVELOPED MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, THERMAL BURN. A REPORT FROM A CONSUMER WAS RECEIVED VIA ANGELINI CUSTOMER SERVICE ON 20-OCT-2024 AND ADDITIONAL INFORMATION WAS RECEIVED AS RESPONSE TO FOLLOW-UP REQUEST ON 21-OCT-2024. ON (B)(6) 2024, A 44-YEAR-OLD FEMALE CONSUMER APPLIED A THERMACARE HEAT WRAP LBH FOR 6 HOURS. INDICATION FOR USE WAS SEVERE BACK PAIN. SHE WORE THE HEAT WRAP DURING WORK. THE CONSUMER SUFFERED THREE BURN BLISTERS (APPROXIMATELY 2 CM) ON HER BACK. SHE STARTED THE TREATMENT WITH A BURN AND WOUND OINTMENT ON (B)(6) 2024. AFTER TWO DAYS, SHE PRICKED THE BLISTERS, AND OPEN WEEPING BLISTERS APPEARED. NORMALLY THE CONSUMER DIDN'T HAVE A SENSITIVE SKIN. PHOTOGRAPHS WERE PROVIDED. THE OUTCOME WAS RECOVERING/RESOLVING. FURTHER INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT; THE BATCH NUMBER WAS REQUESTED, BUT NO LONGER AVAILABLE. OUTCOME: MEDICAL DEVICE SITE BURN: RECOVERING/RESOLVING, BURNS SECOND DEGREE: RECOVERING/RESOLVING, THERMAL BURN: RECOVERING/RESOLVING. THE ACTION TAKEN FOR THE EVENTS IN REGARD TO THE THERMACARE HEAT WRAP LBH WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAP LBH MENTIONS THAT MEDICAL DEVICE SITE BURN, BURNS SECOND DEGREE, 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 HEAT WRAP LBH 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 09-DEC-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110920 THERMACARE LOWER BACK & HIP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention