BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 33MM SINGLE-USE STAPLER

    MDR report key: 887454 · Received July 30, 2007

    Report

    Report Number
    1219930-2007-00409
    Event Type
    Injury
    Date Received
    July 30, 2007
    Date of Event
    June 25, 2007
    Report Date
    July 4, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    07/27/07: INITIAL REPORT SENT TO FDA.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THERE WAS A STAPLE LINE LEAK 3 DAYS POST-OP. RE-OP WAS PERFORMED TO CORRECT. DR THINKS THE TISSUE WAS THICK. PROCEDURE: LAR DOUBLE STAPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 33MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention