BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 1023772 · Received March 21, 2008

    Report

    Report Number
    1220423-2008-00018
    Event Type
    Other
    Date Received
    March 21, 2008
    Report Date
    March 10, 2008
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). ABDOMINAL PAIN [SLURRY] [ABDOMINAL PAIN]. ACUTE ABDOMEN [SLURRY] [ACUTE ABDOMEN]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 03/10/2008 FROM A PHYSICIAN REGARDING A FEMALE PATIENT OF UNKNOWN AGE, (B) (6), WHO EXPERIENCED ABDOMINAL PAIN AND AN ACUTE ABDOMEN AFTER APPLICATION OF SEPRAFILM. THE PATIENT HAD A HISTORY OF SMOKING AND ADHESIONS ON THE RIGHT SIDE. THE PATIENT UNDERWENT A LAPAROSCOPIC LEFT OOPHORECTOMY FOR AN UNKNOWN INDICATION ON AN UNKNOWN DATE. DURING SURGERY, ONE SHEET OF SEPRAFILM WAS CUT INTO PIECES, WATER WAS ADDED AND IT WAS PLACED AS A PASTE IN THE PELVIS. FIVE DAYS POST SURGERY, "THEY FOUND A GOOEY MESS, ACUTE ABDOMEN, NO BOWEL INJURY". FLOSEAL WAS USED AT THE END OF THE CASE. THE PHYSICIAN REPORTED THAT SALINE WAS USED AS AN IRRIGANT DURING SURGERY. NEITHER POWDERED NOR LATEX GLOVES WERE USED AND NO PRODUCTS WERE LEFT BEHIND IN THE ABDOMINAL CAVITY. CATGUT AND SILK SUTURES WERE NOT USED. THE PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE EVENTS AND SEPRAFILM AS DEFINITE (HE STATED THAT "THE GOOEY MESS GOES ALONG WITH THE SEPRAFILM AND "THAT WAS GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention