BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST 5VX

    MDR report key: 16019479 · Received December 20, 2022

    Report

    Report Number
    3005905321-2022-00004
    Event Type
    Injury
    Date Received
    December 20, 2022
    Manufacturer
    KI MOBILITY, LLC
    Product Code
    IOR
    PMA / PMN Number
    K062660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DEALER CALLED IN A COMPLAINT STATING THAT THE END USER HAD 2ND/3RD DEGREE BURNS ON SIDES AND BOTTOM OF FEET. END USER HAS/HAD VERY LITTLE FEELING IN FEET SO IT WAS NOT REALIZED UNTIL MUCH LATER. HAPPENED AFTER EXTENDED TIME IN THE SUN THIS PAST SUMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457345 CATALYST 5VX MECHANICAL WHEELCHAIR IOR KI MOBILITY, LLC CATALYST 5VX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other