BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST 5VX

    MDR report key: 16008567 · Received December 19, 2022

    Report

    Report Number
    3005905321-2022-00002
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    September 18, 2022
    Report Date
    December 14, 2022
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF THE FILING DATE, NO FURTHER INFORMATION HAS BEEN PROVIDED TO KI MOBILITY ON THE ALLEGED INJURY. IT CANNOT BE DETERMINED IF THE DEVICE CONTRIBUTED TO OR CAUSED THE ALLEGED EVENT. DUE TO THE SEVERITY OF THE INJURY, THIS REPORT IS BEING SUBMITTED. IF ANY FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    END USER WAS REACHING FORWARD FOR ITEM ON THE SHELF AT GOODWILL, HER CHAIR FELL FORWARD WITH HER IN IT. SHE HURT LEFT LEG FOLLOWED UP WITH HER DR. HAS COMPOUND FRACTURE BEING TREATED BY DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084679 CATALYST 5VX MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC CATALYST 5VX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization