BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST 5

    MDR report key: 16034178 · Received December 22, 2022

    Report

    Report Number
    3005905321-2022-00007
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 21, 2022
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    UDI-DI
    00850013379026
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED OUT OF AN OVERABUNDANCE OF CAUTION DUE TO THE NATURE OF THE INJURY. THE DEVICE HAS NOT BEEN RETURNED AND NO PARTS HAVE BEEN REQUESTED AS A RESULT OF THIS ADVERSE EVENT. A FOLLOW-UP WILL BE CONDUCTED IF MORE INFORMATION BECOMES AVAILABLE. THE COMPLAINT SUBMITTED DOES NOT MAKE ANY CLAIMS THAT THE DEVICE MALFUNCTIONED OR DEVIATED IN ANY WAY THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    USER IS UNHAPPY WITH THE CHAIR IN GENERAL AND RECENTLY FELL OUT OF THE CHAIR WHEN TRANSFERRING CAUSING HER TO BREAK HER FEMUR. ACCIDENT HAPPENED IN JANUARY AND SPENT SOME TIME IN HOSPITAL. ONCE DEALER RECEIVED THE CHAIR FOR EVALUATION, (B)(6) ASKED THEM NOT TO DO ANYTHING WITH THE CHAIR UNTIL HE COULD LOOK AT IT. NO PARTS/ACTION TO BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880804 CATALYST 5 MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC CATALYST 5 00850013379026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization