BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK AND HIP 8HR L/XL

    MDR report key: 16363374 · Received February 13, 2023

    Report

    Report Number
    3007593958-2023-00009
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 29, 2023
    Report Date
    February 13, 2023
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO PRODUCT TYPE OR 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 (B)(6) 2023, A SPONTANEOUS REPORT FROM THE UNITED STATES VIA EMAIL REGARDING A FEMALE 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 APPLIED A THERMACARE LOWER BACK AND HIP 8 HR L/XL HEAT WRAP AT NIGHT BEFORE SLEEPING FOR AN UNSPECIFIED INDICATION. THE NEXT MORNING AFTER WAKING UP THE CUSTOMER HAD BLISTERS "ALL OVER HER BACKSIDE OF HER HIP AND BACK". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671903 THERMACARE LOWER BACK AND HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention