BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4041062 · Received August 27, 2014

    Report

    Report Number
    9616091-2014-01652
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE FRONT RIGGINGS (B)(4) HAS A FOOTPLATE THAT WAS LOOSE AND THEY WERE UNABLE TO TIGHTEN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522110 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other