BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 2844734 · Received November 8, 2012

    Report

    Report Number
    1119279-2012-00275
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 DURING PREPARATION OF AMVISC PLUS FOR USE, THE CANNULA DETACHED FROM THE SYRINGE WHEN THE SCRUB NURSE PRESSED DOWN ON THE PLUNGER CAUSING THE VISCOELASTIC TO SPILL FROM THE SYRINGE. THERE WAS NO PATIENT CONTACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1