BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO X

    MDR report key: 11713018 · Received April 23, 2021

    Report

    Report Number
    3032618-2021-00004
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 19, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED COMMUNICATION FROM USER'S ATTORNEY ALLEGING THAT THE USER SUSTAINED SEVERE INJURIES TO HIS ELBOW AND FEMUR WHEN THE FORK STEM DISASSEMBLED FROM THEIR WHEELCHAIR, CAUSING THEM TO FALL. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET SPECIFICATIONS WHEN IT LEFT THE FACILITY. THE TILITE USER'S MANUALS STATE: "INSPECT WHEEL/FORK ASSEMBLY/STEM BOLT TO ENSURE THAT STEM BOLT IS SECURE (WHEEL/FORK ASSEMBLY SHOULD NOT HAVE EXCESSIVE PLAY RELATIVE TO THE STEM BOLT BUT SHOULD ROTATE FREELY); IF NECESSARY, TIGHTEN STEM BOLT." REGULAR MAINTENANCE SHOULD BE DONE ON THE CRITICAL PARTS OF THE FRAME. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    WE RECEIVED COMMUNICATION FROM A USER'S ATTORNEY ALLEGING THAT THE USER SUSTAINED INJURIES WHEN THE FORK STEM DISASSEMBLED FROM THEIR CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616103 AERO X WHEELCHAIR IOR TISPORT, LLC AERO X

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R