BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 1884019 · Received October 14, 2010

    Report

    Report Number
    1518293-2010-00130
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 17, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 9/17: (B)(6) REPORTS VIA PHONE, A (B)(6) FEMALE FROM ER HAVING CT CHEST WITH CONTRAST FOR PULMONARY EMBOLI. OPTIRAY 320 LOADED INTO INJECTOR SYRINGE, IV ACCESS ANTECUBITAL VEIN WITH A 20GA GELCO ACCESS DEVICE. INJECTOR TUBING CONNECTED TO IV ACCESS DEVICE WITH A BAXTER NEEDLELESS ADAPTOR. INJECTION PROTOCOL, 5ML/SEC FOR 100ML VOLUME. INJECTION PERFORMED AND APPROX 60ML OF THE CONTRAST INFILTRATED. PT STATED NO PAIN DURING INJECTION, BUT UPON TREATMENT, PT DID STATE PAIN AT THE SITE. SITE SWOLLEN WITH REDNESS. WARM COMPRESS APPLIED, EXTREMITY ELEVATED. PT OBSERVED FOR 20 MINUTES BY RADIOLOGIST, THEN DISCHARGED BACK TO THE ER. NO OTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIVANTAGE DH CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention