BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3901957 · Received June 30, 2014

    Report

    Report Number
    9616091-2014-01107
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE ARMS ON A 9SL WHEELCHAIR ARE BENT SO FAR THAT THEY ARE HITTING THE WHEELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379990 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other