BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM BIORESORBABLE MEMBRANE

    MDR report key: 355956 · Received October 11, 2001

    Report

    Report Number
    1220423-2001-00012
    Event Type
    Injury
    Date Received
    October 11, 2001
    Report Date
    October 11, 2001
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MCN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFECTION. INFO WAS REC'D IN 2001 WHICH INDICATED THAT A PT DEVELOPED INFECTION AFTER AN ILEO ANAL PULL THROUGH PROCEDURE FOR CROHN'S DISEASE IN WHICH SEPARAFILM WAS PLACED. THE SEPRAFILM SHEETS USED WERE FROM THE SEPRAFILM PROCEDURE PACK, LOT NUMBER NOT SPECIFIED. RE-OPERATION WAS REQUIRED IN WHICH NO BOWEL PERFORATION WAS NOTED. THE REPORTER STATED THERE WAS NO PATHOLOGICAL EXPLANATION FOR THIS INFECTION. THE SURGEON IDENTIFIED SEPRAFILM AS A POSSIBLE CAUSE. ADD'L INFO REC'D IN 2001 FROM THE REPORTER INDICATED THAT A MORE LIKELY REASON FOR THE INFECTION WAS NON-COMPLIANCE WITH BOWEL PREP BY THE PT. ADD'L INFO REC'D 8 DAYS LATER FROM THE REPORTER PROVIDED: THE PT UNDERWENT AN ILEOSTOMY IN 2001. 13 DAYS LATER INFECTION WAS NOTED AND THE PT WAS TREATED WITH ANTIBIOTICS. THE LOT NUMBER WAS ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45751 SEPRAFILM BIORESORBABLE MEMBRANE RESORBABLE ADHESION BARRIER MCN GENZYME CORPORATION NA 477551

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention