BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3800892 · Received May 8, 2014

    Report

    Report Number
    9616091-2014-00833
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE ARMS ON THE TREX28RP WHEELCHAIR ARE NOT LOCKING INTO PLACE, ARM SOCKETS ARE NOT STRAIGHT UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277914 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other