BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 299641 · Received October 10, 2000

    Report

    Report Number
    1220423-2000-00032
    Event Type
    Death
    Date Received
    October 10, 2000
    Date of Event
    August 31, 2000
    Report Date
    October 10, 2000
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING IS A CHRONOLOGY OF EVENTS DESCRIBED BY THE REPORTING PHYSICIANS. THE PT HAS A HISTORY OF ULCERATIVE COLITIS DIAGNOSED SINCE 1998. THE PT HAD AN ELECTIVE SURGERY FOR ULCERATIVE COLITIS WHICH CONSISTED OF; 1) ILE0-ANAL J-POUCH ANASTOMOSIS; 2) TOTAL PROCTOCOLECTOMY; 3) PROXIMAL DIVERTING LOOP ILEOSTOMY. THE SURGERY WAS PERFORMED IN 2000. THE OPERATION WAS SUCCESSFUL AND THE PT WOKE UP FROM THE ANESTHESIA AND WAS ALERT, AND CONVERSING WITH THE PHYSICIAN POST-OP. LATER ON THAT POST-OP DAY, APPROX 24 MINUTES BEFORE MIDNIGHT, THE PT WAS FOUND UNRESPONSIVE AND PULSELESS WITH ASYSTOLIC RHYTHM. CPR PROTOCOL WAS CARRIED OUT WITH SERIES OF ADVANCED CARDIAC LIFE SUPPORT PROTOCOL MEDICATIONS WITH NO SUCCESS. THE PT REMAINED ASYSTOLIC AND PULSELESS WITHOUT BLOOD PRESSURE. ATTEMPT AT RESUSCITATION WITH DEFIBRILLATION WAS PERFORMED WITHOUT ANY RESPONSE. AT 17 MINUTES PAST MIDNIGHT, THE PT WAS PRONOUNCED DEAD. THE REPORTING SITE HAS ASSESSED THE EVENT AS UNRELATED TO SEPRAFILM. ALTHOUGH THIS EVENT DOES NOT MEET THE MDR REPORTING CRITERIA, GENZYME IS SUBMITTING THE REPORT DUE TO THE FATAL OUTCOME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM BIORESORBABLE MEMBRANE RESORBABLE ADHESION BARRIER MCN GENZYME CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death