BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 413821 · Received August 29, 2002

    Report

    Report Number
    2647580-2002-00184
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    June 7, 2002
    Report Date
    July 30, 2002
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE INSTRUMENT DID NOT CUT PROPERLY. THE DISTAL DONUT DID NTO FORM PROPERLY. THE PROCEDURE WAS CONVERTED TO AN ILEOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GAG PONCE - USS NA P1G351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other