BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 289299 · Received August 10, 2000

    Report

    Report Number
    1220423-2000-00029
    Event Type
    Death
    Date Received
    August 10, 2000
    Date of Event
    April 1, 2000
    Report Date
    August 9, 2000
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PNEUMOCOCCAL PNEUMONIA. THE FOLLOWING IS A CHRONOLOGY OF EVENTS DESCRIBED BY THE REPORTING PHYSICIANS. THE INFO INCLUDES THEIR EXPERIENCE AT THE REPORTING SITE, FROM ONE PHYSICIAN AT THE ADMITTING SITE, AND FROM ACCOUNTS BY THE PT'S SPOUSE: PT UNDERWENT TOTAL PROCTOCOLECTOMY AND END ILEOSTOMY IN 2000. THE PT WAS DISCHARGED ON POSTOPERATIVE DAY 4 IN GOOD CONDITION. ON POSTOPERATIVE DAY 8 IN 2000, THE SPOUSE SAID THE PT WAS NERVOUS AND ANXIOUS. SPOUSE CALLED 911 AND TOOK THE PT TO A COMMUNITY HOSP. THE PT WAS FOUND TO BE HYPERTENSIVE AND TACHYCARDIC. CHEST X-RAY INDICATED QUESTIONABLE INFILTRATE, POSSIBLY PNEUMOCOCCAL PNEUMONIA, OR BACTEREMIA. THE PT WAS ON LIFE-SUPPORT, BUT THEN THE ORDER WAS GIVEN TO "DO NOT RESUSCITATE". THE PT DIED ON THE SAME DAY. NO AUTOPSY WAS PERFORMED. THE REPORTING PHYSICIAN SUSPECTS THAT THE PT DID NOT DIE OF SEPSIS AS WAS PREVIOUSLY REPORTED, BUT RATHER "LIKELY PNEUMOCOCCAL PNEUMONIA". HE ASSESSED THE RELATIONSHIP AS REMOTELY RELATED TO THE USE OF SEPRAFILM. THE REPORTING PHYSICIAN HAS REQUESTED A COPY OF THE DEATH CERTIFICATE FROM THE ADMITTING HOSP. HOWEVER, HE IS NOT CERTAIN THAT HE WILL BE ABLE TO OBTAIN THIS DOCUMENT OR ANY OTHER DOCUMENTATION CONCERNING THIS CASE. 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 361441

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death