BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 418014 · Received September 19, 2002

    Report

    Report Number
    1220423-2002-00014
    Event Type
    Injury
    Date Received
    September 19, 2002
    Date of Event
    February 13, 2000
    Report Date
    September 19, 2002
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPAIRED HEPATIC FUNCTION. IN 2000, THIS PT UNDERWENT AN ADHESIOTOMY AND ONE SHEET OF SEPRAFILM WAS APPLIED TO THE ABDOMINAL CAVITY. PANSPORIN WAS ADMINISTERED TO PREVENT POST OPERATIVE INFECTION. ON THE FIRST DAY POST OPERATIVE, IMPAIRED HEPATIC FUNCTION, (GOT, GPT, GAMMA GTP AND TOTAL BILIRUBIN) WAS NOTED. NEO MINOPHAGEN WAS INCREASED AND CONTINUED 8 DAYS. NINE DAYS POST OPERATIVELY, THE PT'S HEPATIC FUNCTION IMPROVED AND THE PT RECOVERED. THE TREATING PHYSICIAN ASSESSED THE EVENT AS POSSIBLY RELATED TO THE USE OF SEPRAFILM. NO FURTHER INFO IS ANTICIPATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R