BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE HEATWRAP

    MDR report key: 18869003 · Received March 8, 2024

    Report

    Report Number
    3007593958-2024-00015
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 21, 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

    REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 0

    FOLLOW UP RECEIVED ON 07/03/2024 FROM DIAMED AND INVESTIGATION REPORT RECEIVED ON 11/03/2024. ALL THE INFORMATION WERE MERGED TOGETHER. COMPLAINT NUMBER (B)(4). THE COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4). PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 02-JAN-2024 AND IT IS RECOMMENDED FOR APPROVAL. THE AUDIT TRAIL REVIEW IS POSITIVE PER (B)(4) TRACKWISE DIGITAL COMPLAINTS, EFFECTIVE DATE: 13-FEB-2024. 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. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). 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. THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). DURING THE INVESTIGATION OF THIS COMPLAINT RPT-000097160 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 EVENTS OF BURNS SECOND DEGREE AND THERMAL 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 BURNS SECOND DEGREE AND THERMAL BURN COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENT-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 UNSPECIFIED THERMACARE PRODUCT. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO PRODUCT TYPE OR BATCH NUMBER WAS AVAILABLE FOR VALUATION. 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

    ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE THE FOLLOWING REPORT ON 05-MAR-2024. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 22-FEB-2024. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2024-033699 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 22/FEB/2024 FROM A CONSUMER THROUGH DIAMED (DE3833). THIS CASE REPORT CONCERNS A FEMALE PATIENT, WHO APPLIED THERMACARE HEAT WRAPS (LOT NUMBER: UNKNOWN; EXPIRY DATE: UNKNOWN) FOR UNKNOWN INDICATION. CONCOMITANT MEDICATION(S): [UNKNOWN]. MEDICAL HISTORY: UNKNOWN. ON /JAN/2024, AFTER THERMACARE HEAT WRAPS INITIATION, THE PATIENT DEVELOPED BURNS SECOND DEGREE. ON AN UNKNOWN DATE IN (B)(6) 2024, THE FEMALE CONSUMER (AGE UNKNOWN, BUT REQUESTED) APPLIED THERMACARE HEAT WRAPS (SPECIFIC PRODUCT AND BATCH NUMBER UNKNOWN BUT REQUESTED) FOR AN UNKNOWN INDICATION. SHE EXPERIENCED A BURN SECOND DEGREE. THE BURN HAD TO BE TREATED REGULARLY BY A PHYSICIAN AND WAS CAUSING HER SIGNIFICANT PAIN. THE CONSUMER STATED THAT SHE HAD USED THERMACARE FOR YEARS WITHOUT ANY PROBLEMS AND THAT THIS WAS THE FIRST TIME OF AN ADVERSE EVENT OCCURRING. OUTCOME: BURNS SECOND DEGREE: UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEAT WRAPS WAS UNKNOWN. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BURNS SECOND DEGREE COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENT-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. THE ANTICIPATED DATE OF THE NEXT REPORT IS 12-APR-2024.

    Description of Event or Problem · 0

    ON 20-MAR-2024 ANGELINI S.P.A. PROVIDED BRIDGES CONSUMER HEALTHCARE ADDITIONAL INFORMATION. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 07-MAR-2024. FOLLOW UP INFORMATION RECEIVED ON 07/03/2024: FOLLOW-UP INFORMATION REGARDING THE CONSUMER'S AGE, FURTHER DETAILS OF THE ADVERSE REACTIONS AND THE TREATMENT OF THE BURNS WAS RECEIVED ON (B)(6) 2024. THE CONSUMER WAS 33 YEARS OLD AND EXPERIENCED THE ADVERSE REACTION ON (B)(6) 2024. SHE EVEN SUFFERED FROM AN OPEN BURN WOUND [OFFENE BRANDWUNDE] AND HAD TO SEE THE PHYSICIAN EVERY 2 TO 3 DAYS. AT THE TIME OF THIS REPORT, THE CONSUMER STILL HAD TO TREAT THE WOUND WITH AN OINTMENT. INITIALLY, SHE HAD BEEN TREATED WITH OTHER DRUGS (TABLETS AND OINTMENT). THE TREATING PHYSICIAN STATED THAT THE CONSUMER WOULD DEVELOP A PERMANENT SCAR. THE CONSUMER DISCARDED THE PRODUCT PACK AND NEITHER COULD SPECIFY THE THERMACARE PRODUCT TYPE NOR THE BATCH NUMBER. FOLLOW UP RECEIVED ON (B)(6) 2024 FROM DIAMED AND INVESTIGATION REPORT RECEIVED ON 11/03/2024. ALL THE INFORMATION WERE MERGED TOGETHER. COMPLAINT NUMBER (B)(4). THE COMPLAINT COMPLIES WITH THE REQUIREMENTS STATED IN INVESTIGATION PROCEDURE (B)(4)PROCESSING CONSUMER COMPLAINTS, EFFECTIVE 02-JAN-2024 AND IT IS RECOMMENDED FOR APPROVAL. THE AUDIT TRAIL REVIEW IS POSITIVE PER (B)(4) TRACKWISE DIGITAL COMPLAINTS, EFFECTIVE DATE: (B)(6) 2024. 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. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). 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. FOLLOW UP INFORMATION. THE PI OF THERMACARE HEAT WRAPS MENTIONS THAT BURNS SECOND DEGREE AND THERMAL BURN COULD BE ADVERSE EVENTS OF THIS MEDICAL DEVICE. DECHALLENGE AND RECHALLENGE WERE UNKNOWN. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THERMACARE HEAT WRAPS 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
    711147 THERMACARE HEATWRAP HOT OR COLD DISPOSABLE PACK. IMD BRIDGES CONSUMER HEALTHCARE 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention