BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2955897 · Received February 11, 2013

    Report

    Report Number
    9616091-2013-00230
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED OF AN INCIDENT OF WHERE THE SPOKE WAS BROKEN ON A MANUAL WHEELCHAIR PRODUCT T4X22RDA. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58578 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X22RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other