BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSPEED ULTRA

    MDR report key: 2901133 · Received January 4, 2013

    Report

    Report Number
    2126677-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K013561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DATA NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXAM A PATIENT SUSTAINED A LACERATION FROM THE BENT EDGE OF THE MYLAR WINDOW FRAME AND REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4640 LIGHTSPEED ULTRA SYSTEM, X-RAY, TOMOGRAPHY COMPUTED JAK GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention