BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO SUTURE PREMIUM CEEA

    MDR report key: 35176 · Received August 9, 1996

    Report

    Report Number
    MW1009690
    Event Type
    Death
    Date Received
    August 9, 1996
    Date of Event
    April 22, 1996
    Report Date
    July 31, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    4/11/96 LEFT COLECTOMY WITH LOW ANTERIOR RESECTION. PT DEVELOPED POST-OP LEAK WITH PERITONITIS WITH READMISSION ON 4/21/96. PROGRESSED TO MULTIPLE SYMSTEMS ORGAN FAILURE. ANASTOMOSIS TESTED AT TIME OF SURGERY 4/11/96, SALINE AND AIR WITH NO EXTRAVASATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM CEEA DISPOSABLE STAPLER GAG UNITED STATES SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death