BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAPTITE

    MDR report key: 7604942 · Received June 15, 2018

    Report

    Report Number
    7604942
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LNM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COAPTITE IMPLANT WAS HARD TO PUSH THROUGH SYRINGE AND NEEDLE. STAFF OPENED A SECOND SYRINGE WITH SAME LOT NUMBER AND THEN A THIRD SYRINGE WITH A DIFFERENT LOT NUMBER. THEY ALL HAD THE SAME ISSUE. STAFF OPENED THE SECOND NEEDLE AND HAD THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449405 COAPTITE AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM MERZ NORTH AMERICA, INC. 100103908

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR