BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE BASE SYSTEM

    MDR report key: 2023255 · Received February 15, 2011

    Report

    Report Number
    1518293-2011-00032
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 18, 2011
    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

    COVIDIEN (B)(4) REPORTS, A (B)(6) PT, WITH A MEDICAL HISTORY OF BREAST CARCINOMA, RECEIVED 120ML OF OPTIJECT 350 (IOVERSOL), BY AN UNK ROUTE VIA AN AUTOMATIC INJECTOR (OPTIVANTAGE), IN THE ELBOW ANTERIOR FACE, FOR A THORAX - ABDOMINAL - PELVIC SCAN IN INDICATION OF BREAST CARCINOMA ON (B)(6) 2011. IMMEDIATELY AFTER OPTIJECT 350 ADMINISTRATION, THE PT EXPERIENCED AN INJECTION SITE INFILTRATION OF LESS THAN 10ML ASSOCIATED TO INJECTION SITE PAIN, EDEMA AND HEMATOMA. IT WAS NOT MENTIONED IF THE PT RECEIVED DRUG TO TREAT THE REACTIONS. THE FINAL OUTCOME WAS UNK. THE REPORTER REGARDED THE VENOUS FRAGILITY OF THE PT, THE INJECTION SITE AND THE FLOW INJECTION AS OTHER POSSIBLE CAUSES OF THE INFILTRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention AVASTIN (BEVACIZUMAB)| FEMARA (LETROZOLE)