BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 2013280 · Received March 8, 2011

    Report

    Report Number
    1518293-2011-00034
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    ON (B)(6): COVIDIEN SALES REPORTS TO PRODUCT MONITORING VIA PHONE, CUSTOMER HAS EXPERIENCED SIX PATIENT IV INFILTRATIONS OVER THE LAST COUPLE OF WEEKS. CUSTOMER HAS NOT PROVIDED PATIENT OR PROCEDURAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other