BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2930386 · Received January 22, 2013

    Report

    Report Number
    1518293-2013-00007
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    July 25, 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)(4), VIA EMAIL: A FEMALE PT REC'D OPTIJECT 350 (IOVERSOL) VIA AUTOMATIC INJECTOR, TO PERFORM A SCAN OF THORAX, ABDOMEN AND PELVIS, ON (B)(6) 2012. DURING OPTIJECT INJECTION, SHE EXPERIENCED A MODERATE EXTRAVASATION OF LESS THAN 10 ML WITH LOCAL EDEMA AT INJECTION SITE (FOREARM). THE FINAL OUTCOME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31174 OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other OPTIJECT 350