BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM

    MDR report key: 5172030 · Received October 24, 2015

    Report

    Report Number
    1220423-2015-85715
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    October 16, 2015
    Manufacturer
    GENZYME BIOSURGERY (SEPRAFILM/PACK)
    Product Code
    MCN
    PMA / PMN Number
    P950034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON 16-OCT-2015 FROM THE PATIENT. THIS CASE CONCERNS AN APPROXIMATELY (B)(6) YEARS OLD MALE PATIENT WHO INITIATED TREATMENT WITH SEPRAFILM AND DEVELOPED CONGESTIVE HEART FAILURE/CORONARY FAILURE (SLURRY). THE PATIENT'S PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE (APPROXIMATELY 2 YEARS AGO), THE PATIENT RECEIVED TREATMENT WITH SEPRAFILM (AS REPORTED: SLURRY), TAKEN ONCE (LOT/BATCH NUMBER AND EXPIRATION DATE NOT PROVIDED) FOR LAPAROSCOPY. ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY, THE PATIENT DEVELOPED CONGESTIVE HEART FAILURE (CHF)/CORONARY FAILURE. HE WAS RETAINING FLUID ALL AROUND HIS HEART. IT LASTED FOR ABOUT 48 HOURS AND THEN ONCE HE BEGAN TO "DIURIZE", HE WAS FINE AFTER THAT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED/ RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THIS EVENT CONCERNS A PATIENT WHO REPORTED USE OF SEPRAFILM SLURRY AND FLUID RETENTION / CORONARY FAILURE OR CHF OCCURRING 2 YEARS AGO. NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE GENZYME BIOSURGERY QUALITY ASSURANCE WAS 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. AS A GENERAL POLICY, ALL GENZYME PERSONNEL ARE REQUIRED TO TRAIN ON THE GENZYME AND SANOFI US COMPLIANCE POLICY ON PROMOTION AND DISSEMINATION OF PROMOTIONAL MATERIAL. THIS DOCUMENT CONTAINS STRICT GUIDANCE ON PROMOTING PRODUCTS CONSISTENT WITH THE CURRENT LABELING AND NOT PROMOTING OR DISCUSSING ANY OFF-LABEL USE OF GENZYME OR SANOFI PRODUCTS. IF A LOT NUMBER FOR THIS EVENT IS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WILL BE REOPENED AND A SPECIFIC LOT INVESTIGATION WILL BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2015. PTC RESULTS WERE ADDED. UPON INTERNAL REVIEW, AN ADDITIONAL SYMPTOM OF USED A SEPRAFILM SLURRY WAS ADDED. THE TERM OF FLUID RETENTION/ FLUID AROUND HIS HEART WAS UPDATED TO FLUID RETENTION/ FLUID AROUND HIS HEART (SLURRY) AND CONGESTIVE HEART FAILURE/CORONARY FAILURE WAS UPDATED TO CONGESTIVE HEART FAILURE/CORONARY FAILURE (SLURRY).TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED (B)(6) 2015: THE FOLLOW UP INFORMATION DOES NOT CHANGE THE COMPLETE CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED 21-OCT-2015: THIS CASE CONCERNS A PATIENT WHO RECEIVED SEPRAFLM FOR LAPAROSCOPY. PATIENT HAD FLUID RETENTION AND LATER EXPERIENCED CARDIAC FAILURE OR CONGESTIVE HEART FAILURE. AS THE EVENT START DATE IS NOT KNOWN, DEFINITE TEMPORAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT COULD NOT BE ESTABLISHED. ALSO, LACK OF INFORMATION REGARDING INDICATION FOR LAPAROSCOPIC SURGERY, UNDERLYING CONCURRENT MEDICAL CONDITIONS, PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS PRECLUDES THE COMPREHENSIVE ASSESSMENT OF THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6)-2015 FROM THE PATIENT. THIS CASE CONCERNS AN APPROXIMATELY (B)(6) MALE PATIENT WHO INITIATED TREATMENT WITH SEPRAFILM AND DEVELOPED CONGESTIVE HEART FAILURE/CORONARY FAILURE. THE PATIENT'S PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE (APPROXIMATELY 2 YEARS AGO), THE PATIENT RECEIVED TREATMENT WITH SEPRAFILM (AS REPORTED: SLURRY), TAKEN ONCE (LOT/BATCH NUMBER AND EXPIRATION DATE NOT PROVIDED) FOR LAPAROSCOPY. ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY, THE PATIENT DEVELOPED CONGESTIVE HEART FAILURE (CHF)/CORONARY FAILURE. HE WAS RETAINING FLUID ALL AROUND HIS HEART. IT LASTED FOR ABOUT 48 HOURS AND THEN ONCE HE BEGAN TO "DIURIZE", HE WAS FINE AFTER THAT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED/ RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE RESULT WAS PENDING. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT . PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6)-2015: THIS CASE CONCERNS A PATIENT WHO RECEIVED SEPRAFLM FOR LAPAROSCOPY. PATIENT HAD FLUID RETENTION AND LATER EXPERIENCED CARDIAC FAILURE OR CONGESTIVE HEART FAILURE. AS THE EVENT START DATE IS NOT KNOWN, DEFINITE TEMPORAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT COULD NOT BE ESTABLISHED. ALSO, LACK OF INFORMATION REGARDING INDICATION FOR LAPAROSCOPIC SURGERY, UNDERLYING CONCURRENT MEDICAL CONDITIONS, PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS PRECLUDES THE COMPREHENSIVE ASSESSMENT OF THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703602 SEPRAFILM BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other