BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 4

    MDR report key: 16018249 · Received December 20, 2022

    Report

    Report Number
    3005905321-2022-00005
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    February 19, 2022
    Report Date
    February 21, 2022
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379019
    PMA / PMN Number
    K062660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THERAPIST TOLD DEALER THAT USER WAS REACHING FORWARD FOR SOMETHING IN DINING ROOM, AND SAID THAT LEFT CASTER BOTTOM LEFT ECCENTRIC NUT WORKED ITSELF OUT, IT DOES NOT SEEM BROKEN PER DEALER. BOLT WAS BACKED HALF WAY OUT AND THE WASHER AND NUT WAS MISSING WHEN HE RECEIVED THE CHAIR. USER WAS TAKEN TO HOSPITAL AND DIAGNOSED WITH SUBDURAL HEMATOMA. (BUMP ON HEAD) RETURNED LAST NIGHT TO THE FACILITY. IN THE HOSPITAL NOTES PER THERAPIST, IT STATED NEURO SURGERY WAS CONSULTED AND NO PAIN IN HIS BACK, NO DISTRACTING INJURIES. CT WAS NEG FOR INJURY, HE HAS FULL RANGE OF MOTION AND THE CERVICAL COLLAR WAS CLEARED. CT OF THE HEAD SHOWED SMALL SUBDURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747409 CATALYST 4 MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC CATALYST 4 00850013379019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization