BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 2192936 · Received July 20, 2011

    Report

    Report Number
    1119279-2011-00132
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 23, 2011
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AMVISC PLUS DEVICE LUER WOULD NOT SCREW ONTO THE CANNULA. THIS OCCURRED DURING PREPARATION FOR USE WITH NO PT CONTACT. PLEASE REFERENCE MFR REPORT #1119279-2011-00131.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVISC PLUS VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC 023647

    Patients

    Seq Age Sex Outcome Treatment
    1