BEUDAMED
    FDA Adverse Event Summary report: N

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    MDR report key: 2222707 · Received July 11, 2011

    Report

    Report Number
    1220423-2011-00020
    Date Received
    July 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    ABDOMINAL WALL ABSCESS [ABDOMINAL WALL ABSCESS]. CASE DESCRIPTION: LITERATURE REPORT WAS RECEIVED ON (B)(4) 2011, REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN, WITH GASTRIC CANCER. THIS REPORT IS FROM A LITERATURE ARTICLE TITLED (B)(4). THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR GASTRIC CANCER. ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT HAD A HEALTH CHECK-UP WHERE ENDOSCOPY OF THE UPPER DIGESTIVE TRACT INDICATED A 5MM, 0-1 LB LESION AT THE GASTRIC FUNDUS WITH FADING MUCOSAL CHANGE. BIOPSY OF THE REGION LED TO A DIAGNOSIS OF SIGNET-RING CELL CARCINOMA. ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER INVESTIGATION. THE PATIENT FINALLY WAS DIAGNOSED WITH UNDIFFERENTIATED MICRO GASTRIC CANCER, (B)(4), STAGE IA. ON AN UNKNOWN DATE IN 2011, THE PATIENT HAD LAPAROSCOPIC PROXIMAL GASTRECTOMY. FOR THE PROCEDURE, AN ABOVE UMBILICAL INCISION WAS MADE, THEN 6 PORTS WERE INSERTED INTO PLACE. THE LESION WAS CONFIRMED AS S-TIA (B)(4), STAGE IA. THEN THE LAPAROSCOPIC PROXIMAL GASTRECTOMY WAS STARTED. D1+ LYMPH NODE DISSECTION WAS PERFORMED. RECONSTRUCTION WAS DONE BY DOUBLE TRACT METHOD. ESOPHAGOJEJUNOSTOMY WAS PRACTICED BY OVERLAP METHOD WITH LINER STAPLER. FISTULA FOR INSERTING THE STAPLER WAS SUTURED CONSECUTIVELY IN THE BODY CAVITY. SIDE-TO-SIDE ANASTOMOSIS WAS MADE BETWEEN ANTERIOR WALL OF REMAINING STOMACH AND CONTRALATERAL MESENTERIOLUM OF ELEVATING JEJUNUM BY LINER STAPLER, AND HANGING SUPPORT SUTURE AT 3 POINTS AROUND FISTULA FOR INSERTION TO CLOSE BY LINER STAPLER. USING THE SAME METHOD FOR THE Y BUNDLE, WHICH WAS MADE BY SIDE-TO-SIDE ANASTOMOSIS BY LINER STAPLER IN THE BODY CAVITY, INSERTION FISTULA WAS ELEVATED TO OUTSIDE OF UMBILICAL INCISION AND WAS CLOSED BY MANUAL CONSECUTIVE ONE-LAYER SUTURING. MESENTERIOLUM OF Y BUNDLE AND PETERSEN'S SPACE WAS CLOSED BY SUTURE IN BODY CAVITY. LEAKAGE TEST, LAVAGE AND HEMOSTASIS WERE CONFIRMED. DRAIN WAS PLACED AT SUB HEPATIC AREA AND SEPRAFILM WAS PLACED, THEN INCISION WAS CLOSED TO COMPLETE THE OPERATION. THERE WERE NO COMPLICATIONS DURING SURGERY. IT TOOK 290 MINUTES, WITH 30 ML BLEEDING. THE TUMOR WAS TOO SMALL TO BE SEEN BY THE NAKED EYE. THERE WAS 600 MCM SIZED LESION OF SIGNET-RING CELL CARCINOMA IN THE RESECTED SAMPLE. THERE WAS NO METASTASIS TO LYMPH NODE DISSECTED. ON AN UNKNOWN DATE POST-OPERATIVELY, MILD ABDOMINAL WALL ABSCESS DEVELOPED. ON AN UNKNOWN DATE, THE EVENT ALLEVIATED CONSERVATIVELY. THE PATIENT RECOVERED AND WAS DISCHARGED 21 DAYS AFTER THE OPERATION. THE AUTHORS ASSESSED THE EVENT OF ABDOMINAL WALL ABSCESS AS MILD, AND DID NOT PROVIDE A CAUSALITY ASSESSMENT.

    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 53 YR Other