BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE NECK/SHOULDER/WRIST

    MDR report key: 15692156 · Received October 28, 2022

    Report

    Report Number
    3007593958-2022-00069
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    October 10, 2022
    Report Date
    May 9, 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

    MANUFACTURER NARRATIVE: REPORTABLE NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THE EXPECTED DATE OF THE NEXT REPORT IS (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    BRIDGES CONSUMER HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM ANGELINI S.P.A. ON 09-MAY-2023. ANGELINI S.P.A. RECEIVED THE INFORMATION ON 05-MAY-2023. THE REPORT VERBATIM IS AS FOLLOWS: THERE IS NO BATCH NUMBER AVAILABLE. THEREFORE, FULL INVESTIGATION INTO THE SPECIFIC BATCH IS NOT POSSIBLE AND A SPECIFIC BATCH-RELATED ROOT CAUSE CANNOT BE IDENTIFIED. HOWEVER, THERE ARE PRE-IDENTIFIED RISK FACTORS REGARDING THERMACARE THAT COULD CAUSE A BURN LISTED IN THE HAZARD ANALYSIS (RPT-000097160).IN ADDITION TO THESE HAZARDS, THERE ARE MULTIPLE RISKS THAT ARE OUTSIDE THE CONTROL OF THE MANUFACTURING PROCESS. THESE INCLUDE THINGS LIKE AGE, SKIN CONDITION, MEDICAL CONDITIONS, DEVICE USE ERROR AND OFF-LABEL USE. THE WARNING LABELS ON OUR PRODUCT ARE AIMED AT ADDRESSING THESE RISKS AND RELAY THE APPROPRIATE INSTRUCTIONS FOR USE TO OUR CUSTOMERS TO AVOID BURNS, BLISTERS AND SKIN IRRITATIONS. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. IN SUCH PERSPECTIVE, THIS COMPLAINT WAS SUBJECT TO REVIEW IN ORDER TO IDENTIFY ANY POTENTIAL TRENDS. A 36-MONTH TREND ANALYSIS WAS CONDUCTED ON NECK, SHOULDER, WRIST (NSW) FOR UNKNOWN BATCH NUMBER COMPLAINTS, RELATED TO ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION (INCLUDING BURNS).NONE OF THE COMPLAINTS RETURNED WERE CONFIRMED TO HAVE A MANUFACTURING RELATED PROCESS ROOT CAUSE. MOREOVER, THE SEARCH DID NOT SHOW AN INCREASE OVER TIME FOR 36-MONTHS.THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASSES OF ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION FOR NECK, SHOULDER, WRIST (NSW) PRODUCTS. BASED ON THE HISTORICAL DATA OF THE COMPLAINTS RECEIVED THE RESEARCH WAS PERFORMED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST (INCLUDING BURNS) FOR INVESTIGATION FOR NECK SHOULDER WRIST PRODUCTS. THE DATA DID NOT SHOW AN INCREASE OVER TIME FOR 36-MONTHS.ON THE BASIS OF THIS TECHNICAL FILE IS NOT IMPACTED. CRITICALITY MINOR BASED ON THE INFORMATION PROVIDED, THE EVENT OF BURNS SECOND DEGREE 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. IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) OF THERMACARE APPROVED IN JUNE 2022 BY THE NOTIFIED BODY (NB) ISSUING THE MDR CERTIFICATION, THAT STATES IN THE SECTION "SPECIAL WARNINGS AND PRECAUTIONS FOR USE" THAT THE PRODUCT CAN CAUSE BURNS/BLISTERS, ANGELINI WILL CONSIDER EVENTS OF BURNS (OF ANY GRADE) AS EXPECTED EFFECTS;THEREFORE PI OF THERMACARE NECK SHOULDER WRIST MENTIONS THAT BURNS SECOND DEGREE COULD BE AN ADVERSE EVENT OF THIS MEDICAL DEVICE. TEMPORAL ASSOCIATION ADVERSE EVENT-MEDICAL DEVICE IS PLAUSIBLE. BASED ON THE INFORMATION PROVIDED THE CAUSAL RELATIONSHIP BETWEEN THERMACARE NECK SHOULDER WRIST AND INCIDENT IS CONSIDERED AS POSSIBLE THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN BATCH NUMBER OF NECK SHOULDER WRIST PRODUCT WITH THE SUB CLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED. WITHOUT A VALID BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL EVALUATION CAN NOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THE COMPLAINT WAS EVALUATED TO IDENTIFY ANY POTENTIAL TRENDS. A 36-MONTH TREND ANALYSIS WILL BE CONDUCTED FOR COMPLAINTS WITH AN UNKNOWN BATCH NUMBER SINCE THE DATE OF MANUFACTURE IS UNKNOWN FOR UNKNOWN BATCH NUMBERS. THE SEARCH DID NOT SHOW AN INCREASE OVER TIME FOR 36-MONTHS. CHART SHOWS SEASONAL FLUCTUATIONS. THERE IS NOT A TREND IDENTIFIED. THERE IS NO FURTHER ACTION REQUIRED. THE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 BRIDGES CONSUMER HEALTHCARE RECEIVED THE FOLLOWING REPORT FROM (B)(6) WHO RECEIVED THE REPORT ON (B)(6) 2022. THE REPORT VERBATIM IS AS FOLLOWS: THIS SERIOUS SPONTANEOUS CASE, MANUFACTURER CONTROL NUMBER 2022-028785 IS AN INITIAL REPORT FROM (B)(6) RECEIVED ON (B)(6) 2022 FROM A CONSUMER/OTHER NON-HEALTH PROFESSIONAL THROUGH DIAMED (DE2217). FOLLOW-UP INFORMATION RECEIVED ON 17/OCT/2022 FROM THE CONSUMER THROUGH DIAMED (DE2217), REGARDING PATIENT'S AGE, INDICATION FOR USE, THE ONSET OF ADVERSE REACTION, THE ACTION TAKEN WITH THE DEVICE, THERAPY DURATION AND THE OUTCOME. THE INFORMATION WAS MERGED AND PROCESSED TOGETHER. THIS CASE REPORT CONCERNS A 65-YEARS-OLD FEMALE PATIENT WHO APPLIED THERMACARE NECK SHOULDER WRIST (BATCH NUMBER AND EXPIRY DATE UNKNOWN) FOR SHOULDER PAIN ON (B)(6) 2022. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT REPORTED. ON (B)(6) 2022, AFTER THERMACARE NECK SHOULDER WRIST INITIATION, THE PATIENT EXPERIENCED BURN SECOND DEGREE. AFTER APPROXIMATELY 3 HOURS OF APPLICATION, SHE REMOVED THE HEAT WRAP BECAUSE THE HEAT WAS TOO STRONG. SHE NOTICED THAT SHE HAD SUFFERED A SECOND-DEGREE BURN IN THE UPPER AREA OF HER LEFT SHOULDER THE SIZE OF A 2-EURO PIECE. IN THE PAST, THE CONSUMER HAD APPLIED THERMACARE HEAT WRAPS SEVERAL TIMES WITHOUT COMPLAINTS. THE BATCH NUMBER IS UNKNOWN; THE CONSUMER DISPOSED THE PACKAGE. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. A CRUST HAS FORMED, AND THE HEALING PROCESS IS NOT YET COMPLETE. OUTCOME: BURN SECOND DEGREE: RECOVERING/RESOLVING. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE NECK SHOULDER WRIST WAS DEVICE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835506 THERMACARE NECK/SHOULDER/WRIST HOT OR COLD DISPOSABLE PACK. IMD ANGELINI 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention