BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 266717 · Received March 1, 2000

    Report

    Report Number
    MW1018315
    Event Type
    Malfunction
    Date Received
    March 1, 2000
    Date of Event
    January 19, 2000
    Report Date
    February 2, 2000
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIECE OF 15FR ROUND BLAKE DRAIN BROKE OFF WHILE INSERTING IT. XRAYS TAKEN. NO FBO SEEN. NO INJURY TO PT (PROLONGED SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 15FR ROUND BLAKE DRAIN GCY ETHICON, INC. * 33764

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other