BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE MENSTRUAL HEAT WRAP

    MDR report key: 16473443 · Received March 2, 2023

    Report

    Report Number
    3007593958-2023-00011
    Event Type
    Injury
    Date Received
    March 2, 2023
    Report Date
    April 7, 2023
    Manufacturer
    ANGELINI
    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. INVESTIGATIONAL IN PROGRESS. THE ANTICIPATED DATE OF THE NEXT REPORT IS (B)(6) 2023.

    Additional Manufacturer Narrative · 0

    ON 05-APR-2023, ANGELINI S.P.A. PROVIDED THE FOLLOWING INFORMATION TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 03-APR-2023. FOLLOW UP RECEIVED ON 3-APR-2023 FROM QA DEPARTMENT. COMPLAINT NUMBER (B)(4): THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF MENSTRUAL 8HR PRODUCT WITH A SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY-RELATED TREND WAS IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. DUE TO THE EXCLUSION OF QUALITY DEFECT, THE MOST PROBABLE ROOT CAUSE IS LINKED TO INDIVIDUAL SENSITIVITY AND UNRELATED TO THE MANUFACTURING PROCESS. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID UNDESIRABLE SIDE EFFECTS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, INCLUDING PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT. WITHOUT BATCH INFORMATION AVAILABLE, IT IS IMPOSSIBLE TO ASSIGN A ROOT CAUSE FOR THIS COMPLAINT. TO IDENTIFY A MOST PROBABLE ROOT CAUSE, THERE ARE PRE-IDENTIFIED RISK FACTORS THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160). THERE ARE SEVERAL MATERIAL AND PRODUCT DEFECT RISK FACTORS THAT ARE IDENTIFIED AND MITIGATED TO REDUCE THE RISK OF THESE DEFECTS REACHING OUR CUSTOMERS. WHILE THE SITE TAKES EVERY PRECAUTION TO IDENTIFY POTENTIAL RISK, THERE ARE MULTIPLE RISKS THAT ARE OUTSIDE THE CONTROL OF THE SITE. THESE INCLUDE ASPECTS LIKE AGE, SKIN CONDITION, AND OTHER MEDICAL CONDITIONS. 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. DATA ANALYSIS WAS PERFORMED TAKING THE PERIOD FROM 02-16-2020 TO 02-16-2023 WITH COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SEARCHES RETURNED A TOTAL 16 COMPLAINTS FOR THE MENSTRUAL 8HR PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. OVER TIME FOR 36-MONTHS, THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASSES OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR THE MENSTRUAL 8HR PRODUCTS. THERE IS NO FURTHER ACTION REQUIRED. THE SEARCH DESCRIBED IN THE INVESTIGATION SUMMARY TAKES INTO CONSIDERATION ALL ADVERSE EVENTS. THIS SEARCH WAS NOT SPECIFIC TO BURNS ONLY, THEREFORE IT IS NOT INTENDED TO BE USED FOR DETERMINING SIMILAR INCIDENTS AS PER MIR HELP TEXT OF THE COMMISSION. ACCORDING TO HAZARD ANALYSIS (B)(4), NO NEW RISK WAS IDENTIFIED DURING THE COMPLAINT INVESTIGATION BASED ON THE HISTORICAL DATA OF THE COMPLAINTS RECEIVED THE RESEARCH WAS PERFORMED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR MENSTRUAL 8HR PRODUCTS. THE DATA DID NOT SHOW AN INCREASE OVER TIME FOR 36-MONTHS. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST AND THEREFORE, THE RISK ASSESSMENT INCLUDED IN THE TECHNICAL FILE IS NOT IMPACTED. ANGELINI MEDICAL ASSESSMENT: THE PI OF THERMACARE MENSTRUAL MENTIONS THAT BURNS FIRST 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 MENSTRUAL AND BURNS FIRST DEGREE IS CONSIDERED AS POSSIBLE. THE OVERALL ASSESSMENT FOR THIS CASE IS SERIOUS/LABELED/POSSIBLE THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER OF MENSTRUAL 8HR PRODUCT WITH A SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER A MANUFACTURING EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. DATA ANALYSIS WAS PERFORMED TAKING THE PERIOD FROM 02-16-2020 TO 02-16-2023 WITH COMPLAINT SUB CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. SEARCHES RETURNED A TOTAL 16 COMPLAINTS FOR THE MENSTRUAL 8HR PRODUCTS DURING THIS TIME PERIOD FOR THE CLASS/SUBCLASS. THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR MENSTRUAL 8HR PRODUCTS. DUE TO THE EXCLUSION OF QUALITY DEFECT, THE MOST PROBABLE ROOT CAUSE IS LINKED TO INDIVIDUAL SENSITIVITY AND UNRELATED TO THE MANUFACTURING PROCESS. .

    Description of Event or Problem · 0

    ON (B)(6) 2023, ANGELINI S.P.A. PROVIDED THE REPORT TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE REPORT FROM GERMANY ON (B)(6) 2023. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2023-030115 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON (B)(6) 2023 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH ANGELINI DE(DE2558). THIS CASE REPORT CONCERNS A 31-YEARS-OLD FEMALE PATIENT, WHO APPLIED, AT UNKNOWN DATE, THERMACARE MENSTRUAL, INDICATION PAIN MENSTRUAL, THAT EXPERICENCED BURNS FIRST DEGREE AT UNKNOWN DATE. MEDICAL HISTORY, CONCOMITANT DISEASES/TREATMENT: NO INFORMATION. PRODUCT: THERMACARE MENSTRUAL. LOT NUMBER AND EXP DATE: UNKNOWN. A REPORT FROM A 31 YEAR-OLD FEMALE CONSUMER WAS RECEIVED VIA ANGELINI CUSTOMER SERVICE ON (B)(6) 2023 REGARDING THERMACARE HEAT WRAPS FOR MENSTRUAL PAIN (BATCH NUMBER UNKNOWN, BUT REQUESTED). INDICATION FOR USE WAS MENSTRUAL PAIN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A FIRST-DEGREE BURN [VERBRENNUNG ERSTEN GRADES] WHICH HAD TO BE TREATED BY A PHYSICIAN FOR SEVERAL WEEKS. ACCORDING TO THE CONSUMER, SHE APPLIED THE PATCHES CORRECTLY FOLLOWING THE INSTRUCTIONS FOR USE (NOT WEARING DIRECTLY ON THE SKIN AND NOT EXTENDING THE INDICATED TIME). THE CONSUMER WANTED TO CHECK WHETHER SHE WAS STILL IN POSSESSION OF THE PACKAGING IN ORDER TO PROVIDE THE BATCH NUMBER AND PACK SIZE. FURTHER INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. OUTCOME: BURNS FIRST DEGREE : UNKNOWN. THE ACTION TAKEN FOR THE EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    ON 28-FEB-2023, ANGELINI S.P.A. PROVIDED THE REPORT TO BRIDGES CONSUMER HEALTHCARE. ANGELINI S.P.A. RECEIVED THE REPORT FROM GERMANY ON 16-FEB-2023. ON 22-FEB-2023, ANGELINI S.P.A. RECEIVED ADDITIONAL INFORMATION WHICH WAS PROVIDED TO BRIDGES CONSUMER HEALTHCARE ON 05-APR-2023. THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2023-030115 IS AN INITIAL REPORT FROM GERMANY RECEIVED ON 16/FEB/2023 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH ANGELINI DE(DE2558). THIS CASE REPORT CONCERNS A 31-YEARS-OLD FEMALE PATIENT, WHO APPLIED, AT UNKNOWN DATE, THERMACARE MENSTRUAL, INDICATION PAIN MENSTRUAL, THAT EXPERICENCED BURNS FIRST DEGREE AT UNKNOWN DATE. MEDICAL HISTORY, CONCOMITANT DISEASES/TREATMENT: NO INFORMATION. PRODUCT: THERMACARE MENSTRUAL. LOT NUMBER AND EXP DATE: UNKNOWN. A REPORT FROM A 31 YEAR-OLD FEMALE CONSUMER WAS RECEIVED VIA ANGELINI CUSTOMER SERVICE ON 16-FEB-2023 REGARDING THERMACARE HEAT WRAPS FOR MENSTRUAL PAIN (BATCH NUMBER UNKNOWN, BUT REQUESTED). INDICATION FOR USE WAS MENSTRUAL PAIN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A FIRST-DEGREE BURN [VERBRENNUNG ERSTEN GRADES] WHICH HAD TO BE TREATED BY A PHYSICIAN FOR SEVERAL WEEKS. ACCORDING TO THE CONSUMER, SHE APPLIED THE PATCHES CORRECTLY FOLLOWING THE INSTRUCTIONS FOR USE (NOT WEARING DIRECTLY ON THE SKIN AND NOT EXTENDING THE INDICATED TIME). THE CONSUMER WANTED TO CHECK WHETHER SHE WAS STILL IN POSSESSION OF THE PACKAGING IN ORDER TO PROVIDE THE BATCH NUMBER AND PACK SIZE. FURTHER INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. OUTCOME: BURNS FIRST DEGREE : UNKNOWN. THE ACTION TAKEN FOR THE EVENT IS UNKNOWN. FOLLOW UP: FIRST FOLLOW-UP ATTEMPT WAS PERFORMED ON 21-FEB-2023. ON 22-FEB-2023 IT WAS RECEIVED THAT THE PACKAGE WAS ALREADY THROWN AWAY BY THE PATIENT AND NO INFORMATION ABOUT THE BATCH NO. WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826804 THERMACARE MENSTRUAL HEAT WRAP HOT OR COLD DISPOSABLE PACK. IMD ANGELINI 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention