BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SEPRAFILM)

    MDR report key: 3402924 · Received October 7, 2013

    Report

    Report Number
    1220423-2013-00020
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    July 11, 2013
    Report Date
    August 6, 2013
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFO WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY. NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE GENZYME BIOSURGERY QUALITY ASSURANCE IS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY GENZYME ARE RELEASED FOR SHIPMENT BY QUALITY ASSURANCE ONLY AFTER SUCCESSFUL COMPLETION OF QUALITY CONTROL CERTIFICATE OF ANALYSIS TESTING AND REVIEW OF ALL DEVICE HISTORY RECORDS AND ASSOCIATED MANUFACTURING PROCESS DOCUMENTATION. THIS LOT RELEASE PROCEDURE PROVIDES ASSURANCE THAT ALL PRODUCT LOTS ARE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT SPECIFICATIONS. IN THE EVENT THAT A LOT NUMBER FOR THIS EVENT IS REPORTED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED AND AN INVESTIGATION WILL BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME.

    Description of Event or Problem · 1

    SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN VIA SALES REPRESENTATIVE REGARDING A PT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, DURING AN UNREPORTED OPERATION, SEPRAFILM MEMBRANE (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) WAS PLACED (NUMBER OF SHEETS NOT PROVIDED) AT AN UNREPORTED SITE. THE LOT NUMBER OF SEPRAFILM WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED FLUID ACCUMULATION AT THE SITE OF SEPRAFILM APPLICATION AND FEVER. THE ACTION TAKEN WITH SEPRAFILM TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR BOTH THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE ANY CAUSAL RELATIONSHIP BETWEEN SEPRAFILM WITH BOTH THE EVENTS. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN PROVIDING PATIENT'S INITIALS, PAST MEDICAL HISTORY, THERAPY DETAILS, LOT NUMBER, EVENTS INFO, CONCOMITANT AND TREATMENT MEDICATIONS. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR CHOLEDOCHAL CYST (2003), FEVER, PAIN, HEPATECTOMY, BILIARY STONES, LOOSE STOOLS AND ABDOMINAL DISTENSION. ON (B)(6) 2013, THE PT UNDERWENT LAPAROTOMY AND SEPRAFILM MEMBRANE WAS PLACED ON BOWEL LOOPS, JUST BELOW THE INCISION. ON (B)(6) 2013, POST-OPERATIVE DAY 2, THE PT DEVELOPED LOW GRADE FEVER AND STARTED SIPS ORAL. ON POST-OPERATIVE DAY 3, THE PT DEVELOPED HIGH GRADE FEVER AND WOUND PAIN. ON (B)(6) 2013 (POST-OPERATIVE DAY 4), THE PT WAS GIVEN SOFT DIET, FOLLOWING WHICH SHE DEVELOPED BILIOUS VOMITING. ON POST-OPERATIVE DAY 7, DUE TO PERSISTENT FEVER, TREATMENT WITH INJECTION MEROPENEM WAS STARTED, DOSE AND ROUTE NOT PROVIDED, AND A REPEAT HEMOGRAM SHOWED DROP IN HEMOGLOBIN. ON POST-OPERATIVE DAY 8, COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH SHOWED HYPODENSE COLLECTION ALONG THE ANTEROLATERAL ASPECTS OF THE RIGHT ABDOMINAL WALL AT THE SITE OF INCISION CORRESPONDING TO THE SITE OF SEPRAFILM PLACEMENT. THERE WAS NO LEAK FOUND. ON POST OPERATIVE DAY 9, THERE WAS COPIOUS AMOUNT SEROUS DISCHARGE THROUGH WOUND. IT WAS REPORTED THAT SWAB TAKEN FROM THE DISCHARGE GREW E.COLI WHICH WAS SENSITIVE TO AMIKACIN. ON POST-OPERATIVE DAY 10, THE PT STARTED TREATMENT WITH AMIKACIN AND LINELOZID FOLLOWING WHICH THE EVENT OF FEVER AND BILIOUS VOMITING RESOLVED. IT WAS REPORTED THAT THE DISCHARGE WAS CONSIDERABLY REDUCED OVER 2 DAYS AFTER SWAB CULTURE. CONCOMITANT MEDICATIONS INCLUDED MAGNEX FORTE. THE REPORTING PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP BETWEEN SEPRAFILM WITH THE EVENTS OF FEVER AND WOUND DISCHARGE AS HIGHLY PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507166 SEPRAFILM (SEPRAFILM) BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK) 12NPT02

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization PREV MEDS = UNK| SULBACTAM (CON.)| CEFOPERAZONE