BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISTAR LE, INJECTOR SYSTEM

    MDR report key: 1373752 · Received May 1, 2009

    Report

    Report Number
    1518293-2009-00101
    Event Type
    Injury
    Date Received
    May 1, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 2, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT CONFIRMED WITH THE OPERATOR THE INJECTOR IS WORKING CORRECTLY. OPERATOR STATED THAT NO SERVICE EVAL IS NEEDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING AN MRA RENAL PROCEDURE, THE VEIN BLEW AND CONTRAST WAS LEAKING UNDER THE SKIN IN THE PT'S HAND. THE PT DID NOT COMPLAIN OF ANY PAIN OR DISCOMFORT DURING INJECTION; SHE WAS TAKEN TO THE ER FOR PRECAUTIONARY REASONS. THE AMOUNT OF CONTRAST (GAD) INFILTRATED IS UNK, HOWEVER, THERE WAS NO CONTRAST ON THE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISTAR LE, INJECTOR SYSTEM INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO. OPTISTAR LE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR