BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3062135 · Received April 16, 2013

    Report

    Report Number
    9616091-2013-00633
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER END USER SEAT IS STRETCHED OUT, SCREW FELL OUT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162869 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TLX8HM280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other