BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4201735 · Received October 27, 2014

    Report

    Report Number
    9616091-2014-02245
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 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

    PER (B)(6), THE AXLE BOLT BROKE ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681602 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other