BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL 2CT

    MDR report key: 13716182 · Received March 9, 2022

    Report

    Report Number
    3007593958-2022-00012
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 4, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE WAS LIMITED DEVICE-SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL ASSESSMENT CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. NO PRODUCT QUALITY-RELATED TREND WAS IDENTIFIED FOR THE SUBCLASS HEAT CELLS DAMAGED LEAKING. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES, INCLUDING PROCESS TESTING, THERMAL TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PACKAGED PRODUCT.

    Description of Event or Problem · 0

    ON 10-FEB-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER REGARDING A (B)(6) FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY INCLUDED ASTHMA, DIABETES, "NEARLY BLIND", AND MYELODYSPLASTIC SYNDROME. THE REPORTER DECLINED TO PROVIDE CONCOMITANT PRODUCTS. ON AN UNSPECIFIED DATE, APPROXIMATELY SINCE 2017, THE CONSUMER HAS APPLIED APPROXIMATELY 4 THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS (LOT NUMBERS NOT PROVIDED; ONE EXPIRATION DATE WAS KNOWN 15-JAN-2022) PER WEEK WITHOUT ISSUES. ON UNSPECIFIED DATES, REPORTED AS "RECENT", THE CONSUMER EXPERIENCED ONE HEAT WRAP DID NOT HEAT UP. SHE ALSO EXPERIENCED ONE OF THE HEAT WRAPS BROKE. IT WAS FURTHER CLARIFIED THAT IT LEAKED. THE CONSUMER DISCARDED THE PRODUCTS AND WAS UNABLE TO PROVIDE ANY FURTHER SPECIFIC DEVICE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539178 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention