BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 2192942 · Received July 20, 2011

    Report

    Report Number
    1119279-2011-00131
    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 WAS FOUND TO HAVE NO LUER LOCK TO CONNECT TO. THIS OCCURRED DURING PREPARATION FOR USE WITH NO PATIENT CONTACT. PLEASE REFERENCE MANUFACTURE REPORT #1119279-2011-00132.

    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