BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK AND HIP 8HR L/XL

    MDR report key: 15858517 · Received November 23, 2022

    Report

    Report Number
    3007593958-2022-00077
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Report Date
    November 4, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER, A MANUFACTURING AND TECHNICAL 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. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISK OF BLISTERS AND OTHER SKIN IRRITATIONS. THE MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE PACKAGED PRODUCT QUALITY.

    Description of Event or Problem · 0

    ON 04-NOV-2022 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER PUT ON A THERMACARE LOWER BACK AND HIP L/XL HEAT WRAP AND THE WRAP CAME APART. IT WAS CLARIFIED THAT THE HEAT WRAP CAME APART WHERE THE CLOTH CONNECTS TO THE HEATED PART DISCONNECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896491 THERMACARE LOWER BACK AND HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK IMD ANGELINI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention