BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD DAVOL, INC.

    MDR report key: 442403 · Received February 9, 2003

    Report

    Report Number
    MW1027503
    Event Type
    Other
    Date Received
    February 9, 2003
    Date of Event
    December 1, 2002
    Report Date
    February 9, 2003
    Manufacturer
    DAVOL INC., SUBSIDIARY OF C.R. BARD INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE LEAKS. THIS IS THE THIRD DEVICE IN THIS LOT NUMBER TO LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD DAVOL, INC. HYDROFLEX LI LAPAROSCOPIC IRRIGATION TUBING SET GCJ DAVOL INC., SUBSIDIARY OF C.R. BARD INC. +$$801070441GMN1XW 41GMN126

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other