BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2942797 · Received February 4, 2013

    Report

    Report Number
    1531186-2013-00408
    Date Received
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. THE DEALER STATED THAT THE SEAT HAS CRACKED WHERE THE PATIENT'S LEGS WOULD HANG OFF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46963 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other