BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGUSEAL

    MDR report key: 5517531 · Received March 22, 2016

    Report

    Report Number
    5517531
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    October 31, 2015
    Report Date
    November 5, 2015
    Manufacturer
    HALYARD (LAB) IRVINE
    Product Code
    NZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BEFORE OPENING THE PACKAGE OF INTEGUSEAL, IT WAS NOTICED THE DEVICE WAS ALREADY ACTIVATED DUE TO THE LIQUID IN THE PACKAGE. NO PATIENTS WERE AFFECTED. A NEW PACKAGE WAS USED FROM THE SAME LOT NUMBER AND WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174104 INTEGUSEAL SEALANT, MICROBIAL NZP HALYARD (LAB) IRVINE P00203417

    Patients

    Seq Age Sex Outcome Treatment
    1