BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERI-STRIPS DRY

    MDR report key: 417262 · Received September 16, 2002

    Report

    Report Number
    2183620-2002-00010
    Event Type
    Death
    Date Received
    September 16, 2002
    Date of Event
    July 31, 2002
    Report Date
    August 20, 2002
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    07/30/2002 - PATIENT UNDERWENT A ROUX-EN-Y LAPAROSCOPIC BARIATRIC PROCEDURE. 2002 - LEAK DISCOVERED, PATIENT TAKEN BACK TO SURGERY, LEAK WAS REPAIRED. 08/2002 - PATIENT TRANSFERRED TO ANOTHER FACILITY FOR POSSIBLE HEMODIALYSIS. 2002 - PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY STAPLE LINE BUTTRESS FTL SYNOVIS SURGICAL INNOVATIONS PSD 4506 ETSN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H| R ETHICON ENDOSURGICAL STAPLER AND STAPLES.