BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 2831201 · Received November 6, 2012

    Report

    Report Number
    1518293-2012-00207
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    June 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    PMA / PMN Number
    K042744
    Product Problem
    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

    A PT EXPERIENCED EXTRAVASATION DURING OPTIJECT 350 (IOVERSOL) ADMINISTRATION, IN (B)(6) 2012. THE FINAL OUTCOME WAS NOT REPORTED. ACCORDING TO THE OPTIJECT 350 USED AS REFERENCE SAFETY INFO, EXTRAVASATION IS LISTED. BASED ON THE INFO CURRENTLY AVAILABLE AND ACCORDING TO THE OFFICIAL (B)(6) METHOD OF CAUSALITY ASSESSMENT, THE COMPANY DID NOT ASSESS THE CAUSAL RELATIONSHIP (EXTRAVASATION). (B)(6) REPORTS: IT IS NOT POSSIBLE ANYMORE TO IDENTIFY THE PTS AND GET DETAILED INFO ABOUT EACH CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other