BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 698988 · Received October 3, 2005

    Report

    Report Number
    1216677-2005-00027
    Event Type
    Malfunction
    Date Received
    October 3, 2005
    Report Date
    September 30, 2005
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    EJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN AND ASSISTANT REPORT THEY USED THIS DEVICE BEFORE, BUT THIS TIME IT SEEMED TO MALFUNCTION. THEY SAID THE NEEDLE CAME OFF AND STABBED THE PHYSICIAN IN THE THIGH. CENTRAL SUPPLY WAS UNABLE TO PROVIDE ANY MORE INFORMATION ON THE DEVICE. REFERENCE MEDWATCH 3400280000-2005-8012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARTRIDGE SYRINGE EJI COOPERSURGICAL, INC. 22181 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R