BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2990749 · Received March 5, 2013

    Report

    Report Number
    9616091-2013-00369
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    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

    (B)(4) THE DEALER REPORTED THAT THE TREX20FR MECHANICAL WHEELCHAIR CROSSBRACE WELD WAS BROKEN AT TUBE HOLDING THE SEAT UPHOLSTERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93021 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX20FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other