BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE WITH PEDESTAL

    MDR report key: 1962858 · Received January 13, 2011

    Report

    Report Number
    1518293-2010-00172
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 16, 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

    (B)(6) REPORTS VIA E-MAIL, (B)(6) REPORTS AN IV CONTRAST INFILTRATION VIA E-MAIL. (B)(6) Y/O PT UNDERGOING A CT SCAN OF ARTERIES FOR CAROTID ARTERY STENOSIS. CONTRAST; OPTIJECT 350. INJECTION PROTOCOL; 4ML/SEC FOR 100ML VOLUME. IV ACCESS SITE, FOREARM. IV ACCESS DEVICE TYPE NOT REPORTED. IMMEDIATELY AFTER OPTIJECT 350 ADMINISTRATION, THE PT EXPERIENCED AN INJECTION SITE EXTRAVASATION OF LESS THAN 10ML OF CONTRAST MEDIA. ONE MINUTE AFTER OPTIJECT 350 ADMINISTRATION, THE PT ALSO PRESENTED INJECTION SITE EDEMA AND INJECTION SITE HEMATOMA. IT WAS NOT MENTIONED IF THE PT RECEIVED ANY SYMPTOMATIC TREATMENT. THE FINAL OUTCOME WAS UNK. THE REPORTER (PHYSICIAN) CONSIDERED THE INTENSITY OF THE EXTRAVASATION AS MILD AND REGARDED THE PREEXISTING VENOUS FRAGILITY AS OTHER POSSIBLE CAUSE OF THE EXTRAVASATION.

    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 67 YR Other