BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3781665 · Received April 30, 2014

    Report

    Report Number
    9616091-2014-00781
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATED THAT THE CROSSBRACES BROKE RIGHT AT THE BOLT ATTACHING POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260525 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other