BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE LOWER BACK & HIP 8HR L/XL

    MDR report key: 14014338 · Received April 5, 2022

    Report

    Report Number
    3007593958-2022-00020
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Report Date
    March 31, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE CANNOT BE IDENTIFIED. THERE IS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER OR RETURN SAMPLE, 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 WRAP/PATCH/PAD TOO HOT. THIS IS A COMPLAINT OF THE WRAP BEING TOO HOT: THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. 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 TELEPHONE REGARDING A MALE CONSUMER (AGE NOT PROVIDED) WHO WAS USING THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS FROM A 2-PACK BOX. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS APPLIED TOPICALLY FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE, AFTER USING THE HEAT WRAP, ONE OF THE WRAPS WAS TOO HOT AND THE OTHER DID NOT HAVE ENOUGH HEAT. THE CONSUMER HAD NO FURTHER COMPLAINTS AND DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812651 THERMACARE LOWER BACK & HIP 8HR L/XL HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip GLD179-201021 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention