BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2GX

    MDR report key: 7791497 · Received August 16, 2018

    Report

    Report Number
    3032618-2018-00003
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 16, 2018
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET SPECIFICATIONS AS ORDERED BY THE DEALER WHEN IT LEFT THE FACILITY. THE DEALER AND/OR A THERAPIST MEASURE THE USER FOR A WHEELCHAIR. TISPORT AS THE MANUFACTURER BUILDS THE CHAIR BASED ON THE MEASUREMENTS PROVIDED TO US FROM THE DEALER AND/OR THERAPIST. IN THIS CASE, THE DEALER AND/OR THERAPIST SPECIFIED A CHAIR THAT HAD A 1 INCH SHORTER FRAME THAN THE PREVIOUS FRAME THE END USER WAS ACCUSTOMED TO, AND DID NOT ACCOMMODATE FOR DESIGN DIFFERENCES BETWEEN THE SERIES 1 AND SERIES 2 2GX TO PRODUCE A CHAIR WITH THE SAME FOOTPRINT.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE AREA SALES MANAGER, THE CUSTOMER'S WHEELCHAIR ALLEGEDLY TIPPED FORWARD CAUSING HER TO FRACTURE HER LEG. WE HAVE NOT BEEN PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE INJURY, OTHER THAN THESE ALLEGATIONS, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629091 2GX WHEELCHAIR IOR TISPORT, LLC 2GX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization