BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 617525 · Received June 24, 2005

    Report

    Report Number
    1220423-2005-00022
    Event Type
    Injury
    Date Received
    June 24, 2005
    Date of Event
    April 26, 2005
    Report Date
    May 11, 2005
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFLAMED BOWEL. THE PATIENT UNDERWENT REPAIR OF A VENTRAL HERNIA IN 2005 IN WHICH SEPRAMESH IP WAS PLACED ON THE ANTERIOR ABDOMINAL WALL. ONE DAY FOLLOWING PLACEMENT OF SEPRAMENS IP, THE PATIENT BECAME TACHYCARDIC AND COMPLAINED OF A MORE THAN NORMAL AMOUNT OF POST-OPERATIVE PAIN. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND INTUBATED. A RE-EXPLORATION OF THE ABDOMEN SHOWED THICKENED AND DILATED SMALL BOWEL WHICH HAD BEEN IN CONTACT WITHSEPRAMESH IP. THE SEPRAMESH IP WAS REMOVED AND ALLODERM WAS PLACED. THE PATIENT HAS NOT RECOVERED. IT WAS THE OPTION OF THEY PHYSICIAN THAT THE EVENT WAS SEVERE IN INTENSITY AND PROBABLY RELATED TO SEPRAMENS IP. H6. THIS CONCLUSION CODE WAS CHOSEN BECAUSE NO SAMPLE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED BY THE USER FACILITY. GENZYME QUALITY ASSURANCE IS UNABLE TO PERFORM AN EVALUATION OR LOT HISTORY REVIEW. THIS REPORT WAS PREVIOUSLY SUBMITTED IN 2005 FOR SEPRAMESH UNDER MDR 1221601-2005-000001. UPON INTERNAL REVIEW IN 2005, IT WAS FOUND THAT THE SUSPECT DEVICE WAS SEPRAMESH IP AND NOT SEPRAMESH, AS HAD BEEN ORIGINALLY REPORTED. THEREFORE, THE REPORT FOR MDR# 1221601-2005-00001 IS CONDISERED VOID FOR SEPRAMESH. THE COMPLETE CASE IS BEING SUBMITTED FOR THE CORRECT SUSPECT DEVICE, SEPRAMESH IP, UNDER MDR# 1220423-2005-000022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAMESH IP BIORESORBABLE COATING/ PERMANENT MESH MCN GENZYME BIOSURGERY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R