BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3884487 · Received June 19, 2014

    Report

    Report Number
    1531186-2014-02185
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS INCORRECTLY FILED WITH MFG REPORT NUMBER 1531186-2014-02185. THIS DOES NOT REFLECT THE CORRECT MFG NUMBER FOR THE MANUFACTURER. (B)(4)

    Description of Event or Problem · 1

    THE PROVIDER STATES THE LEFT SIDE RIGGING WAS BROKEN BY A VETERAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361303 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX GVTRSX58

    Patients

    Seq Age Sex Outcome Treatment
    1 Other