BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 2896933 · Received January 4, 2013

    Report

    Report Number
    9615350-2013-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MOTION CONCEPTS
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE RB-CMT QUICK RELEASE DUAL MOUNT HARDWARE HANDLES WERE BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4586 WHEELCHAIR COMPONENTS 890.3920 IOR MOTION CONCEPTS RB-CMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other