BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DMI

    MDR report key: 19712864 · Received July 10, 2024

    Report

    Report Number
    1000143485-2024-24164
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Report Date
    July 3, 2024
    Manufacturer
    FOSHEN NANHAI KJT REHABILITATION EQUIPMENT
    Product Code
    ILS
    UDI-DI
    00041298993797
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRIED TO FOLLOW UP WITH CUSTOMER BUT HAVE NOT RECEIVED A RESPONSE. SAMPLE NOT AVAILABLE FOR INSPECTION.

    Description of Event or Problem · 0

    I PURCHASED ONE FOR MY FATHER FROM AMAZON AFTER HE HAD BOTH LEGS AMPUTATED. AFTER A FEW USES, WE HAD AN INCIDENT WHERE HE NEARLY FELL. I BELIEVE IT IS DUE TO THE CAM SYSTEM ON THE ARMS. THE LENGTH OF EACH PIN MAKE THEM INSUFFICIENT FOR WHEN SOMEONE PRESSES BACKWARDS ON THE ARM, WHICH THEN DISLODGES THE PIN AND CAUSES THE ARM TO DROP WITH FULL FORCE AND MY FATHER FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351558 DMI HD DROP ARM COMMODE ILS FOSHEN NANHAI KJT REHABILITATION EQUIPMENT 802-1204-0300 00041298993797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male