BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 3922150 · Received May 23, 2014

    Report

    Report Number
    1119279-2014-00097
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA BROKE OFF DURING THE REMOVAL OF THE PLUG. THERE WAS NO PT CONTACT. ADD'L INFO HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309197 AMVISC PLUS SURGICAL VISCOELASTIC MATERIAL LZP LIFECORE BIOMEDICAL, LLC 60081L 025097

    Patients

    Seq Age Sex Outcome Treatment
    1