BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE BASE SYSTEM

    MDR report key: 2220308 · Received August 16, 2011

    Report

    Report Number
    1518293-2011-00135
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    A (B)(6) FEMALE PATIENT RECEIVED 30 CC OF INTRAVENOUS OPTIRAY 320 (LOT AND EXPIRATION DATE UNKNOWN) ON 07/18/2011 FOR CT ABDOMINAL/PELVIS TO EVALUATE ABDOMINAL PAIN. THE PATIENT EXPERIENCED EXTRAVASATION AT THE SITE OF INJECTION, RIGHT ARM, WITH MODERATE SWELLING AND THE EXAM WAS STOPPED. PRIOR TO THE INJECTION, SALINE WAS INJECTED INTO THE VEIN AND PLACEMENT WAS CONFIRMED. THE FACILITY OFFERED HOT COMPRESS AS TREATMENT BUT THE PATIENT REFUSED. PER THE FACILITY PATIENT WAS AWAKE, LUCID AND LEFT ON HER OWN ACCORD. THE PATIENT WAS SEEN LATER AT AN URGENT CARE FACILITY. THE PATIENT OUTCOME WAS NOT KNOWN. MEDICAL HISTORY INCLUDED NO KNOWN ALLERGIES, DIARRHEA. PER THE IMAGING FACILITY, THE PATIENT WAS DEHYDRATED AT THE TIME OF SERVICE ON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other