BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1001974 · Received February 21, 2008

    Report

    Report Number
    1219930-2008-00161
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    September 10, 2007
    Report Date
    January 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THREE DAYS AFTER SURGERY, A FISTULA IS DISCOVERED. ALLEGEDLY, THE STAPLING LINE WAS INCORRECT. THE PT WAS RE-OPERATED. NO FURTHER PROCEDURE OR PT DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS U7D40

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R