BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 17139739 · Received June 15, 2023

    Report

    Report Number
    2438477-2023-00058
    Event Type
    Injury
    Date Received
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    ITI
    UDI-DI
    00822383933924
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE WAS NOTIFIED THROUGH CLAIMS OF A COMPLAINT INVOLVING A POWERED WHEELCHAIR. THE END USER'S ATTORNEY STATED THAT THE "FOOTREST BECAME LOOSE AND [THE END USER] SUFFERED A CUT ON HIS TOE FROM THE SCREW WHICH LED TO AN INFECTION AND SUBSEQUENTLY THAT TOE HAD TO BE AMPUTATED." THERE WERE NO ADDITIONAL DETAILS AS TO WHAT TYPE OF MEDICAL TREATMENT WAS SOUGHT WITHIN THE INITIAL COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024676 DRIVE POWERED WHEELCHAIR ITI WU'S TECH CO., LTD. TITANAXS-22CS 00822383933924

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| O