BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2930387 · Received January 22, 2013

    Report

    Report Number
    1518293-2013-00009
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    June 8, 2012
    Report Date
    January 22, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K042744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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 (B)(6) 2012: NOTIFICATION REC'D FROM COVIDIEN (B)(6), VIA EMAIL: A (B)(6) MALE PT WEIGHING (B)(6), REC'D 100 ML OF (IOVERSOL) BY IV ROUTE, VIA AUTOMATIC INJECTOR FOR SCAN OF ARTERIAL VESSELS FOR AORTIC ANEURYSM, ON (B)(6) 2012. DURING OPTIJECT INJECTION, HE EXPERIENCED A MILD EXTRAVASATION BETWEEN 11 AND 30ML WITH EDEMA AT INJECTION SITE (ELBOW LINE). THE FINAL OUTCOME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30333 OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other