BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3103392 · Received May 9, 2013

    Report

    Report Number
    9616091-2013-00779
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE REHAB THERAPIST WHO WAS WITH THE USER THEY DID NOT NOTICE AN INJURY, HOWEVER, THE END USER HAS ALLEGED AN INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE PROVIDER, THE END USER WAS BEING PUSHED UP A RAMP AND THE FRONT CASTER ON THE LEFT SIDE BENT AND THE END USER WAS THROWN FROM THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203172 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 Other