BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2921386 · Received January 17, 2013

    Report

    Report Number
    9616091-2013-00097
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 17, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TREX28RF MECHANICAL WHEELCHAIR CASTER BEARINGS WERE STRIPPED, RESULTING IN A DIFFICULT MANEUVERING OF THE UNIT. THERE WAS NO PATIENT INJURY REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26613 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other