BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE STRUCTURAL BALLOON TROCAR

    MDR report key: 1061163 · Received June 4, 2008

    Report

    Report Number
    1061163
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 4, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE METAL RING ON THE LAP HERNIA STRUCTURAL BALLOON FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE STRUCTURAL BALLOON TROCAR TROCAR, BALLOON, HERNIA REPAIR GCJ COVIDIEN UNITED STATES SURGICAL CORPORATION OMST10SB P7D0216

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR