BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1053123 · Received May 16, 2008

    Report

    Report Number
    1527736-2008-03128
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 5, 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 ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, AIR TESTING SHOWED POSITIVE LEAK RESULTS. SURGEON DID A DIVERSIONARY COLOSTOMY.

    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