BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4112269 · Received September 23, 2014

    Report

    Report Number
    9616091-2014-01958
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 4, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE LEFT SIDE OF THE FRAME NEAR THE AXLE IS BROKEN AT A WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591663 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RDAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other