BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEAT WRAPS

    MDR report key: 19420539 · Received May 29, 2024

    Report

    Report Number
    3007593958-2024-00026
    Event Type
    Injury
    Date Received
    May 29, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BRIDGES CONSUMER HEALTHCARE
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    ON 12-JUN-2024, ANGELINI S.P.A. PROVIDED ADDITIONAL INFORMATION TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECIEVED THE INFORMATION ON (B)(6) 2024. THE REPORT VERBATIM IS AS FOLLOWS: IR RECEIVED ON (B)(6) 2024 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4) . THIS INVESTIGATION WAS CONDUCTED FOR AN UNSPECIFIED THERMACARE 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. 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 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 WI-000098885 PROCESSING CONSUMER COMPLAINTS, EFFECTIVE (B)(6) 2024 AND IT IS RECOMMENDED FOR APPROVAL. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE BURN 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 BASED ON THE INFORMATION PROVIDED, THE EVENT OF MEDICAL DEVICE SITE 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 USE OF THE DEVICE. THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT MEDICAL DEVICE SITE BURN COULD BE AN ADVERSE EVENT 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 WRAPS AND THE REPORTED ADVERSE EVENT WAS CONSIDERED AS POSSIBLE. THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH NUMBER OF THERMACARE PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO PRODUCT TYPE OR 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. DUE TO THE FACT THAT THIS COMPLAINT WAS RECEIVED FOR AN UNKNOWN PRODUCT TYPE AND NO LOT INFORMATION IS AVAILABLE, THERE IS NOT ENOUGH DATA AVAILABLE TO CONDUCT TRENDING. SHOULD MORE DATA BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED AND TRENDING WILL BE COMPLETED, IF POSSIBLE. CONSIDERING THE CURRENT INFORMATION AVAILABLE FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    BRIDGES CONSUMER HEALTHCARE RECEIVED THE REPORT ON 09-MAY-2024. ON 29-MAY-2024, ANGELINI S.P.A. PROVIDED ADDITIONAL INFORMATION. THE VERBATIM REPORT IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2024-034481 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 09/MAY/2024 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH DIAMED (DE4136). THIS CASE REPORT CONCERNS A MALE PATIENT (AGE: UNKNOWN), WHO APPLIED THERMACARE HEAT WRAPS (BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN) USED FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): UNKNOWN. MEDICAL HISTORY: UNKNOWN. ON UNSPECIFIED DATE, AFTER THERMACARE HEAT WRAPS INITIATION, THE PATIENT EXPERIENCED. MEDICAL DEVICE SITE BURN. AFTER APPLYING THE PRODUCT, THE CONSUMER EXPERIENCED HIS SKIN BEING BURNT. OUTCOME: MEDICAL DEVICE SITE BURN: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEAT WRAPS WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT MEDICAL DEVICE SITE BURN COULD BE AN ADVERSE EVENT 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 WRAPS AND THE REPORTED ADVERSE EVENT 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
    1837531 THERMACARE HEAT WRAPS HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention