BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST

    MDR report key: 7812502 · Received August 24, 2018

    Report

    Report Number
    3005905321-2018-06798
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 24, 2018
    Manufacturer
    KI MOBILITY LLC
    Product Code
    IOR
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE END USER FELL OUT OF THEIR CHAIR WHEN THE CROSS BRACES HAD BROKEN AND RECEIVED A HEAD INJURY THAT REQUIRED HOSPITAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653219 CATALYST FOLDING WHEELCHAIR IOR KI MOBILITY LLC CATALYST 5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization