BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL

    MDR report key: 16053234 · Received December 27, 2022

    Report

    Report Number
    3007593958-2022-00097
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    December 26, 2022
    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 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) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A MALE (AGE NOT PROVIDED) WHO USED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP. MEDICAL HISTORY AND CONCOMITANT PRODUCT USE WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAP FOR AN UNKNOWN INDICATION. ON AN UNSPECIFIED DATE, AFTER WEARING THE HEAT WRAP FOR 2 HOURS, THE CONSUMER EXPERIENCED "REALLY BAD BLISTERS" ON HIS BACK. HE NOTED HIS BECAME INFECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444462 THERMACARE LOWER BACK & HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI 00305733010396

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention