BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKMOVE TRANSFER AID

    MDR report key: 10860252 · Received November 18, 2020

    Report

    Report Number
    3009481053-2020-00026
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 16, 2020
    Report Date
    November 18, 2020
    Manufacturer
    HANDICARE AB
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HANDICARE USA, THE IMPORTER, NOTIFIED THE MANUFACTURER, HANDICARE AB, OF THE INCIDENT ON (B)(6) 2020. THIS UNIT HAS NOT YET BEEN RETURNED. WHEN RECEIVED, IT WILL BE SENT TO HANDICARE AB FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE FINDINGS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS GETTING UP WITH A 2 STAFF ASSIST. PATIENT WAS ON THE EQUIPMENT WHEN THE LEFT LEG BROKE CAUSING THE PATIENT TO FALL TO THE FLOOR. HE HAS LEFT HIP PAIN, AND LEFT GLUTEAL ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330581 QUICKMOVE TRANSFER AID TRANSFER AID IKX HANDICARE AB 400801334

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR