BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE WITH PEDESTAL

    MDR report key: 1880252 · Received October 19, 2010

    Report

    Report Number
    1518293-2010-00137
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 27, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    CUSTOMER REPORTED VIA FAX, A (B)(6), WITH A MEDICAL HISTORY OF EPIGLOTTIC AND GLOTTIC SQUAMOUS CELL CARCINOMA, BAD VENOUS STATUS (VENOUS FRAGILITY), OBESITY, ADDICTION TO DRUGS, RECEIVED 70 ML OF OPTIJECT 350 (IOVERSOL), BATCH NUMBER AND EXP DATE UNK, BY IV ROUTE (RATE FLOW: 1.5 ML/S) ON THE EXTERNAL FACE OF THE ELBOW VIA AUTOMATIC INJECTOR (BRAND NAME OPTIVANTAGE), FOR A CT SCAN OF THE THORAX AND ENT/SINUS. NO INFO ON CONCOMITANT MEDICATION WAS PROVIDED. AT 3 MINUTES AFTER OPTIJECT 350 INJECTION, THE PT EXPERIENCED AN INJECTION SITE EXTRAVASATION OF 11 TO 30 ML OF CONTRAST MEDIA WITH INJECTION SITE EDEMA AND INJECTION SITE HEMATOMA. IT WAS NOT MENTIONED IF THE PT RECEIVED DRUG TO TREAT THE REACTIONS. THE FINAL OUTCOME WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention