BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVISC PLUS VENTILATOR

    MDR report key: 3929249 · Received June 19, 2014

    Report

    Report Number
    1119279-2014-00144
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    LIFECORE BIOMEDICAL, LLC.
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORTER THE REPORTED PROBLEM WAS NOTICED WITH 3 UNITS FROM THE SAME LOT. HOWEVER, THE EXACT NUMBER OF EVENTS/PROCEDURES ASSOCIATED WITH THE 3 UNITS OR SPECIFIC EVENT DATES HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 THE AMVISC SYSTEM CAME APART, BETWEEN THE LUER LOCK AND SYRINGE. THIS OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360789 AMVISC PLUS VENTILATOR SURGICAL VISCOELASTIC MATERIAL LZP LIFECORE BIOMEDICAL, LLC. 60081L 025052

    Patients

    Seq Age Sex Outcome Treatment
    1