BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM (SEPRAFILM)

    MDR report key: 5529354 · Received March 28, 2016

    Report

    Report Number
    1220423-2016-00005
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    November 9, 2015
    Report Date
    March 18, 2016
    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

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2016 FROM AN OBSTETRICIAN/GYNECOLOGIST. THIS CASE INVOLVES A (B)(6) YEAR OLD FEMALE PATIENT WHO DEVELOPED ABSCESS AFTER PLACEMENT OF SEPRAFILM. MEDICAL HISTORY WAS RELEVANT FOR UNDERLYING DISEASE (SURGERY INDICATION): INTRAUTERINE INFECTION AND CEPHALO-PELVIC DISPROPORTION. THE PATIENT HAD NO CONCURRENT CONDITION BEFORE SURGERY. NO PAST DRUG AND CONCOMITANT MEDICATION WAS REPORTED. ON (B)(6) 2015, EMERGENCY CAESAREAN SECTION WAS PERFORMED AND SEPRAFILM WAS APPLIED TO THE UTERINE SUTURE SITE AND THE CORPUS UTERI (FORM, ROUTE, DOSE, FREQUENCY, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED). ON (B)(6) 2015 (LATENCY: 11 DAYS), MODERATE ABSCESS DEVELOPED. THE ABSCESS WAS FORMED ONLY IN THE CORPUS UTERI APPLICATION SITE AND SEPRAFILM APPLIED TO THE UTERINE SUTURE SITE SHOWED NO REMARKABLE FINDINGS. THE ABSCESS SITE SPECIMEN WAS SENT FOR CULTURE, BUT NO BACTERIA WERE IDENTIFIED. AS OF (B)(6) 2016, SHE HAD RECOVERED FROM THE EVENT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED/ RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH PTC NUMBER: (B)(4). 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 WERE 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 PROVIDED ASSURANCE THAT ALL PRODUCT LOTS WERE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WAS DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT WAS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WOULD BE REOPENED AND A LOT INVESTIGATION WOULD BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: ABSCESS (ABSCESS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION) REPORTING OBSTETRICIAN/GYNECOLOGIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE REPORTING OBSTETRICIAN/GYNECOLOGIST'S COMMENT: INTRAUTERINE INFECTION; AND SURGICAL INVASION, CONCOMITANT DRUG, OR CONCOMITANTLY-USED MEDICAL DEVICE (UNSPECIFIED) WERE CONSIDERED TO BE ALTERNATIVE EXPLANATIONS FOR THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 14-APR-2016. THE PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 14-APR-2016: THE FOLLOW UP INFORMATION DOES NOT CHANGE THE OVERALL CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED (B)(6) 2016: THIS CASE CONCERNS A FEMALE PATIENT WHO RECEIVED SEPRAFILM AFTER A CAESAREAN SECTION AND DEVELOPED ABSCESS AT THE APPLICATION SITE. THE CAUSAL ROLE OF THE PRODUCT IN THE OCCURRENCE OF THE EVENT CANNOT BE DENIED AS THERE IS REASONABLE POSSIBILITY OF APPLICATION SITE COMPLICATIONS AFTER THE USE OF SEPRAFILM, HOWEVER, PATIENT'S UNDERLYING CONDITION OF INTRA-UTERINE INFECTION, SURGICAL INVASION ALONG WITH USE OF DEVICE (UNSPECIFIED) ACTS AS CONFOUNDING FACTORS FOR A COMPREHENSIVE CASE ASSESSMENT.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 18-MAR-2016 FROM AN OBSTETRICIAN/GYNECOLOGIST. THIS CASE INVOLVES A (B)(6) YEAR OLD FEMALE PATIENT WHO DEVELOPED ABSCESS AFTER PLACEMENT OF SEPRAFILM. MEDICAL HISTORY WAS RELEVANT FOR UNDERLYING DISEASE (SURGERY INDICATION): INTRAUTERINE INFECTION AND CEPHALO-PELVIC DISPROPORTION. THE PATIENT HAD NO CONCURRENT CONDITION BEFORE SURGERY. NO PAST DRUG AND CONCOMITANT MEDICATION WAS REPORTED. ON (B)(6) 2015, EMERGENCY CAESAREAN SECTION WAS PERFORMED AND SEPRAFILM WAS APPLIED TO THE UTERINE SUTURE SITE AND THE CORPUS UTERI (FORM, ROUTE, DOSE, FREQUENCY, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED). ON (B)(6) 2015 (LATENCY: 11 DAYS), MODERATE ABSCESS DEVELOPED. THE ABSCESS WAS FORMED ONLY IN THE CORPUS UTERI APPLICATION SITE AND SEPRAFILM APPLIED TO THE UTERINE SUTURE SITE SHOWED NO REMARKABLE FINDINGS. THE ABSCESS SITE SPECIMEN WAS SENT FOR CULTURE, BUT NO BACTERIA WERE IDENTIFIED. AS OF (B)(6) 2016, SHE HAD RECOVERED FROM THE EVENT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED/ RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING. DIAGNOSIS: ABSCESS (ABSCESS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). REPORTING OBSTETRICIAN/GYNECOLOGIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE. REPORTING OBSTETRICIAN/GYNECOLOGIST'S COMMENT: INTRAUTERINE INFECTION; AND SURGICAL INVASION, CONCOMITANT DRUG, OR CONCOMITANTLY-USED MEDICAL DEVICE (UNSPECIFIED) WERE CONSIDERED TO BE ALTERNATIVE EXPLANATIONS FOR THE EVENT. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 23-MAR-2016: THIS CASE CONCERNS A FEMALE PATIENT WHO RECEIVED SEPRAFILM AFTER A CAESAREAN SECTION AND DEVELOPED ABSCESS AT THE APPLICATION SITE. THE CAUSAL ROLE OF THE PRODUCT IN THE OCCURRENCE OF THE EVENT CANNOT BE DENIED AS THERE IS REASONABLE POSSIBILITY OF APPLICATION SITE COMPLICATIONS AFTER THE USE OF SEPRAFILM, HOWEVER, PATIENT'S UNDERLYING CONDITION OF INTRA-UTERINE INFECTION, SURGICAL INVASION ALONG WITH USE OF DEVICE (UNSPECIFIED) ACTS AS CONFOUNDING FACTORS FOR A COMPREHENSIVE CASE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184346 SEPRAFILM (SEPRAFILM) BIORESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY (SEPRAFILM/PACK)

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization