BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1020436 · Received February 29, 2008

    Report

    Report Number
    1527736-2008-01278
    Event Type
    Injury
    Date Received
    February 29, 2008
    Date of Event
    January 12, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OF A LOW ANTERIOR RESECTION, A LEAK WAS DISCOVERED. THE PATIENT WAS TAKEN BACK INTO SURGERY AND THE LEAK WAS FIXED WITH SUTURES AND THERE WAS NO OTHER PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention