BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2993533 · Received March 7, 2013

    Report

    Report Number
    9616091-2013-00389
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RIGHT SIDE LEGREST DOES NOT MOVE UP OR DOWN WHICH MAY PROHIBIT THE USER FROM GETTING NEEDED SUPPORT FOR THEIR LEGS OR FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97135 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other