BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3123094 · Received May 21, 2013

    Report

    Report Number
    9616091-2013-00853
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH WOBBLY WHEELS ON A 9SL MANUAL WHEELCHAIR. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR THE CHAIR TO NOT MAINTAIN ITS INTENDED WEIGHT-BEARING STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224804 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Other