BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO X

    MDR report key: 12029312 · Received June 18, 2021

    Report

    Report Number
    3032618-2021-00007
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    July 19, 2015
    Report Date
    June 18, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A LETTER WAS RECEIVED FROM THE LEGAL COUNSEL OF A DEALER CLAIMING THAT A USER WAS INJURED WHILE TRANSFERRING FROM HER WHEELCHAIR. THE COMMUNICATION STATED, "THE FOOTREST WAS ATTACHED TO A METAL ROD, WHICH WAS IN TURN CONNECTED TO THE BODY OF THE WHEELCHAIR USING A METAL BRACKET. THE METAL ROD EXTENDED ABOVE THE CONNECTING BRACKET." THE LETTER FURTHER CLAIMS THAT THE USER FELL ONTO THE ROD WHICH IMPALED HER IN THE RECTUM, CAUSING "SEVERE INTERNAL INJURIES." THE ISSUE IS CURRENTLY IN LITIGATION WITH NO FURTHER DETAILS MADE AVAILABLE. A SUPPLEMENTARY REPORT WILL FOLLOW AS NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER ALLEGEDLY FELL ONTO A METAL ROD THAT WAS SECURED TO THE FOOTREST OF HER WHEELCHAIR. THE FALL RESULTED IN INTERNAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922348 AERO X MANUAL WHEELCHAIR IOR TISPORT, LLC AERO X

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R