BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 441419 · Received February 4, 2003

    Report

    Report Number
    1220423-2003-00001
    Event Type
    Injury
    Date Received
    February 4, 2003
    Date of Event
    December 22, 2002
    Report Date
    February 4, 2003
    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

    ABSCESS, SEPSIS, FEVER, DIC. A REPORT RECEIVED FROM A PHYSICIAN ON 01/06/2003, INDICATED THAT A PT , WITH A HISTORY OF ADHESIVE ILEUS AND REFLUX ESOPHAGITIS WHO UNDERWENT ADHESIOTOMY FOR ADHESIVE ILEUS IN 2002. TWO SHEETS OF SEPRAFILM WERE APPLIED UNDER THE MIDLINE INCISION. ANTIBIOTICS WERE ADMINISTERED PRIOR TO SURGERY TO PREVENT POST OPERATIVE INFECTION. ON THE EVENT DAY, THE PT DEVELOPED FEVER (40 C), AN ABSCESS AND SEPSIS. THE FOLLOWING DAY, 3 LESIONS OF FLUID ACCUMULATION WERE OBSERVED ON A CT OF THE ABDOMEN. ONE LESION HAD DEVELOPED INTO AN ABSCESS LOCATED NEAR THE SITE WHERE SEPRAFILM HAD BEEN APPLIED. THE PT'S WBC DECREASED TO 3800 THAT WAS BELIEVED TO BE SECONDARY TO SEPSIS. DIC (DISSEMINATED INTRAVASCULAR COAGULATION) WAS ALSO NOTED AND BOTH THE SEPSIS AND DIC WERE IN GRADUAL REMISSION. APPROXIMATELY TWO WEEKS LATER, THE FEVER RE-OCCURRED. THE IVH (INTRAVENOUS HYPERALIMENTATION) CATHETER AND LEFT SUBCLAVIAN VEIN WERE COMPLETELY OCCLUDED DUE TO CLOT FORMATION. THE CATHETER WAS REMOVED AND MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCU AUREUS) WAS DETECTED ON THE TIP. THE PT RECOVERED WITH UNK SEQUELAE. THE TREATING PHYSICIAN ASSESSED THE EVENTS AS PROBABLY RELATED TO THE USE OF SEPRAFILM. FURTHER INFO IS ANTICIPATED. ACTION TAKEN: DEC, 2002 - MIRACLID (ULINASTATIN) I.V. 300,000 UNITS; FRESH FROZEN HUMAN PLASMA I.V. 6 UNITS; FOY (GABEXATE MESILATE) I.V. 1500MG; TIENAM (IMIPENEM CILASTATIN SODIUM) I.V. 2G; AMIKACIN SULFATE I.V. 400MG.

    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 74 YR Life Threatening