BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 5

    MDR report key: 7287150 · Received February 21, 2018

    Report

    Report Number
    3005905321-2018-04872
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 20, 2018
    Manufacturer
    KI MOBILITY LLC
    Product Code
    IOR
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE LEFT FRONT CASTER HOUSING BOLT BROKE CAUSING HIM TO BE THROWN FROM THE CHAIR, HE TUMBLED TO BOTTOM OF RAMP STRIKING A 4X4 POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131159 CATALYST 5 FOLDING MECHANICAL WHEELCHAIR IOR KI MOBILITY LLC CATALYST 5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1