BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3970916 · Received July 31, 2014

    Report

    Report Number
    9616091-2014-01376
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THE FRAME IS NOT WELDED CORRECTLY. THE PINS FOR THE FRONT RIGGINGS WILL NOT FIT WITH THE PLATE. THE PIN REST IS NOT WELDED CORRECT ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447820 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other