BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2921313 · Received January 17, 2013

    Report

    Report Number
    9616091-2013-00095
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 17, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN END USER HAS REPORTED THAT DURING A TRANSFER OUT OF HIS WHEELCHAIR THE PLASTIC THAT HOLDS THE ARM IN PLACE BROKE OFF. NO INJURY. IT WAS REPORTED THAT THIS PRODUCT IS OVER 5 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25881 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other