BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13180410 · Received January 6, 2022

    Report

    Report Number
    3007593958-2021-00051
    Event Type
    Injury
    Date Received
    January 6, 2022
    Report Date
    January 6, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THE SITE INVESTIGATED THIS COMPLAINT BY REVIEWING THE DEVICE HISTORY RECORDS AND MANUFACTURING CONTROLS. THE REVIEW OF THE DEVICE HISTORY RECORDS, BATCH THERMAL RECORDS, AND PRODUCTION CONTROLS MET THE PRODUCT RELEASE CRITERIA. CONSUMER REPORTS SHE HAD " SECOND DEGREE BURNS IN ALL AREAS OF THE BODY WHERE SHE WAS USING IT". THE CAUSE OF THE CONSUMER STATING SHE HAD "SECOND DEGREE BURNS IN ALL AREAS OF THE BODY WHERE SHE WAS USING IT" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. THIS IS AN ADVERSE EVENT FOR SECOND DEGREE BURNS IN ALL AREAS OF THE BODY WHERE SHE WAS USING IT; RISK CALCULATION CANNOT BE DETERMINED AS THERE IS NO REASONABLE SUGGESTION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    ON 08-DEC-2021, A SPONTANEOUS REPORT WAS RECEIVED FROM THE UNITED STATES VIA TELEPHONE REGARDING A FEMALE (AGE NOT REPORTED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE THE CONSUMER USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP (EXPIRATION DATE: 31-JAN-2024; LOT NUMBER: GA0052). ON AN UNSPECIFIED DATE, AFTER USING A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP, THE CONSUMER EXPERIENCED BURNS. IT WAS FURTHER STATED THAT SHE HAD SECOND DEGREE BURNS IN ALL AREAS OF THE BODY WHERE SHE WAS USING IT. THE CONSUMER NOTED THAT SHE USED IT AS DIRECTED. FOLLOW-UP ATTEMPTS HAVE BEEN UNSUCCESSFUL IN ESTABLISHING CONTACT WITH THE CONSUMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348693 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip GA0052 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention