BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2930385 · Received January 22, 2013

    Report

    Report Number
    1518293-2013-00006
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    May 25, 2012
    Report Date
    January 22, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K042477
    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) 2013 COVIDIEN (B)(6) REPORTS: A (B)(6) MALE PT, WEIGHING (B)(6), W/O VENOUS SYSTEM PROBLEM, REC'D 100ML OF OPTIJECT 300 (IOVERSOL) BY IV ROUTE IN THE FOREARM, VIA AN INJECTOR AT RATE OF 2ML/SEC, FOR A SCAN OF SPINE FOR CERVICOBRACHIAL NEURALGIA, ON (B)(6) 2012. DURING OPTIJECT INJECTION HE EXPERIENCED AN EXTRAVASATION (BETWEEN 31 AND 100ML) AT INJECTION SITE. THE FINAL OUTCOME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29653 OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other OPTIJECT 300 (IOVERSOL)