BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3913721 · Received July 3, 2014

    Report

    Report Number
    9616091-2014-01143
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    END USER HAD HER FEET PLACED ON FOOT PLATE AND IT CRACKED ON A (B)(4) WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389656 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX20P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other