BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14118360 · Received April 15, 2022

    Report

    Report Number
    3007593958-2021-00056
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ANGELINI
    Product Code
    IMD
    UDI-DI
    00305733010037
    Product Problem
    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 AND PRODUCTION CONTROLS MET THE PRODUCT RELEASE CRITERIA. CONSUMER REPORTS SHE "NOTICED THERE WAS BLACK ON THE INSIDE OF IT. THE CONSUMER NOTED IT LOOKED LIKE ONE OF THE LITTLE PADS HAD BEEN LEAKING STUFF ON THE HEAT WRAP." WITHOUT THE PHYSICAL SAMPLE FOR EVALUATION, THE ROOT CAUSE OF THE CONSUMER REPORTING SHE "NOTICED THERE WAS BLACK ON THE INSIDE OF IT. THE CONSUMER NOTED IT LOOKED LIKE ONE OF THE LITTLE PADS HAD BEEN LEAKING STUFF ON THE HEAT WRAP" CANNOT BE DETERMINED. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURING SITE. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN PROCESS TESTING, AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE.

    Description of Event or Problem · 0

    ON 04-SEP-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING A FEMALE CONSUMER WHO USED THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS. MEDICAL HISTORY AND CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE THE CONSUMER OPENED UP A BOX OF THERMACARE LOWER BACK AND HIP 8HR L/XL HEAT WRAPS AND NOTICED THERE WAS BLACK ON THE INSIDE OF IT. THE CONSUMER NOTED IT LOOKED LIKE ONE OF THE LITTLE PADS HAD BEEN LEAKING STUFF ON THE HEAT WRAP. SHE THOUGHT THAT DURING THE PACKAGING AND STITCHING WENT THROUGH THE WRAP CAUSING LEAKAGE OF BLACK SUBSTANCES ON THE WRAP IN TWO AREAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907574 THERMACARE LOWER BACK & HIP 8HR L/XL 2CT HOT OR COLD DISPOSABLE PACK. IMD ANGELINI ThermaCare HeatWraps - Lower Back & Hip ET2209 00305733010037

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention