SEPRAFILM
Report
- Report Number
- 2246315-2018-00762
- Event Type
- Injury
- Date Received
- December 24, 2018
- Date of Event
- October 23, 2018
- Report Date
- July 17, 2019
- Manufacturer
- GENZYME CORPORATION(FRAMINGHAM)
- Product Code
- MCN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PERITONITIS (CHEMICAL) [CHEMICAL PERITONITIS] ([LOW GRADE FEVER]) VESICOUTERINE POUCH ABSCESS [URINARY BLADDER ABSCESS] VESICOUTERINE POUCH ABSCESS [UTERINE ABSCESS] ([PYREXIA], [TACHYCARDIA], [PAIN], [CHILLS], [SHIVERING]) CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON (B)(6) 2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM (LP) (B)(4) UNDER REFERENCE (B)(4) ON (B)(6) 2019 AND TRANSMITTED TO SANOFI. THIS CASE INVOLVES A 32 YEARS OLD FEMALE PATIENT (160 CM AND 57.8 KG) WHO EXPERIENCED PERITONITIS (CHEMICAL), VESICOUTERINE POUCH ABSCESS AND VESICOUTERINE POUCH ABSCESS, WHILE SHE WAS TREATED WITH THE USE OF MEDICAL DEVICE CARBOXYMETHYLCELLULOSE, SODIUM HYALURONATE [SEPRAFILM]. DATA REGARDING THIS PREGNANCY WERE RECEIVED RETROSPECTIVELY, I.E. AFTER PREGNANCY OUTCOME WAS KNOWN. THE REPORTED PERITONITIS (CHEMICAL), MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING, VESICOUTERINE POUCH ABSCESS, VESICOUTERINE POUCH ABSCESS, PYREXIA UP TO 38.5 DEGREE C, TACHYCARDIA, STRONG PAIN, CHILLS AND SHIVERING OCCURRED AT UNKNOWN GESTATION PERIOD. THE DATE OF LAST MENSTRUAL PERIOD WAS NOT REPORTED. THE ESTIMATED DUE DATE WAS NOT REPORTED. THE ACTUAL DATE OF DELIVERY WAS NOT REPORTED. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING SEASONAL ALLERGY, AND BREECH DELIVERY, AND WAS NON-TOBACCO USER. NOTES: INPATIENT. CONCOMITANT MEDICATIONS INCLUDED RANITIDINE HYDROCHLORIDE (RANITIDINE [RANITIDINE HYDROCHLORIDE]) FOR PREMEDICATION; CEFMETAZOLE SODIUM (CEFMETAZOLE SODIUM) FOR PREMEDICATION; LIDOCAINE (XYLOCAINE #1) FOR PRODUCT USED FOR UNKNOWN INDICATION; AND BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE (MARCAIN + ADRENALIN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ALLERGIC PREDISPOSITION UNDERLYING DISEASE: CHILDBIRTH. USE OF SEPRALAP: NONE. CONCURRENT CONDITION BEFORE SURGERY: NONE. HISTORICAL CONDITION: NONE. DIABETES MELLITUS: NONE. PREOPERATIVE UNDERLYING DISEASE (SURGICAL INDICATION): BREECH PRESENTATION - LABOR INDUCTION. PATIENT'S CONDITION: PREOPERATIVE CONDITION: GENERALLY HEALTHY, GOOD NUTRITION STATUS, NO ANAEMIA, NO RADIOTHERAPY. LABORATORY TESTS REGARDING INFECTION AND INFLAMMATION: WBC WERE BETWEEN 17000 AND 18000), BETWEEN 11000 AND 12000, AND BETWEEN 9000 AND 10000. CRP WAS BETWEEN 9 AND 10 ((B)(6) 2018). ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR CAESAREAN SECTION FOR DELIVERY (URGENT), AND UNDERWENT A SURGERY (INTRAOPERATIVE HYPERTHERMIC THERAPY: NONE). FOUR SHEETS OF SEPRAFILM WERE APPLIED TO THE UTERINE WOUND AND ANTERIOR SURFACE. APPLICATION SITE OF SEPRAFILM: UTERINE WOUND AND ANTERIOR SURFACE. DIRECT APPLICATION TO THE ANASTOMOSIS SITE: NONE. CONDITION OF APPLICATION: FAVORABLE. PRE-EXISTING ADHESION: NONE, ADHESIOLYSIS: NOT PERFORMED. INTRAPERITONEAL REGION. PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE, INTRAPERITONEAL IRRIGATION: NONE. ANASTOMOSIS OF RESECTION SITE. RESECTION SITE: NONE, PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE. ANASTOMOSIS METHOD FOR THE RESECTION SITE: HAND SUTURE, INTERRUPTED ANASTOMOSIS. SUTURE: INNER LAYER, OUTER LAYER: VICRYL (ABSORBABLE, SYNTHETIC, MULTI THREAD). STATUS OF OPERATIVE FIELD: ASEPTIC (CLEAN) SURGERY LAPAROTOMY WOUND SUTURE LAYER. LENGTH OF LAPAROTOMY INCISION: 10 CM, SUTURE LAYER: 3 LAYERS. ANASTOMOSIS METHOD FOR THE FIRST LAYER (PERITONEUM): CONTINUOUS SUTURE, SUTURE: ABSORBABLE, SYNTHETIC, MULTI THREAD (VYCRYL) ANASTOMOSIS METHOD FOR THE SKIN: HAND SUTURE, INTERRUPTED ANASTOMOSIS. ABSORBABLE, SYNTHETIC, MONO THREAD. PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE OPERATIVE TIME: APPROXIMATELY 39 MINUTES, HAEMORRHAGE VOLUME: 900, BLOOD TRANSFUSION: NONE. OTHER CONCOMITANTLY USED MEDICAL DEVICE: NONE. IN (B)(6) 2018, THE PATIENT RECEIVED CEFMETAZOLE AFTER THE CAESAREAN SECTION. ON (B)(6) 2018 (POSTOPERATIVE DAY 1 AFTER THE CAESAREAN SECTION), WBC WAS 17100, AND FRACTION AND CRP WERE NOT MEASURED. THE BODY TEMPERATURE WAS AROUND 36°C (36°C OR ABOVE AND BELOW 37°C) DURING DAYTIME, AND THE PATIENT PRESENTED WITH MILD PYREXIA BETWEEN 37°C AND 38°C FROM THE EVENING. AN ANALGESIC DRUG LOXOPROFEN WAS USED ON AN AS-NEEDED BASIS WHEN HAVING PAIN. THE PATIENT EXPERIENCED PERITONITIS (CHEMICAL) (CONFIRMED WITH CT SCAN) (TREATMENT: TAZOPIPE). THE EXPRESSION SITE WAS OBVIOUSLY THE SITE WHERE SEPRAFILM WAS APPLIED TO. HISTOLOGICAL EXAMINATION, IF THE EVENT WAS CONSIDERED TO BE FOREIGN BODY REACTION: INFLAMMATORY EXUDATE, CONSISTENT WITH HYALURONATE INCLUSION. SPECIMEN: ASCITES, UTERINE BLEEDING. GENERAL AEROBES AND GENERAL ANAEROBES: NOT DETECTED. SURGICAL SITUATION: THE CHILD IN BREECH PRESENTATION WAS DELIVERED ROUTINELY WITH TRANSVERSE SKIN INCISION. THE FIRST LAYER OF THE MYOMETRIUM WAS ANASTOMOSED WITH INTERRUPTED SUTURES USING 0 VICRYL DETACH (PLUS), AND THE SECOND LAYER OF THE MYOMETRIUM WAS ANASTOMOSED WITH CONTINUOUS SUTURES USING 1 VICRYL. HAEMOSTASIS WAS CONFIRMED, SEROUS MEMBRANE REMAINED NON-SUTURED, AND SEPRAFILM WAS APPLIED TO THE SEROUS MEMBRANE INCISION SITE. SUBSEQUENTLY, THE LAPAROTOMY WAS CLOSED WITH CONTINUOUS ANASTOMOSIS OF THE RETROPERITONEUM WITH 0 VICRYL. NO DRAIN WAS PLACED. ON (B)(6) 2018 AND (B)(6) 2018 (POSTOPERATIVE DAY 2 AND 3), THE PATIENT HAD NO PYREXIA. ON (B)(6) 2018 (POSTOPERATIVE DAY 4), WBC WAS 11200, BAND + SEG WERE 77.5%, CRP WAS 8.49. THE BODY TEMPERATURE WAS 38.2°C AT AROUND NOON, AND THE PATIENT HAD CHILLS. SUBSEQUENTLY, THE PYREXIA TENDED TO RESOLVE TOWARD EVENING. THE PATIENT STARTED TO RECEIVE AN IRON PREPARATION FERROMIA, AND EXAMINATION SHOWED A HAEMATOMA IN THE UTERINE WOUND ON ULTRASOUND. ANTIBIOTIC THERAPY WAS CONTINUED, AND CHANGED TO AMPICILLIN/SULBACTAM (ABPC/SBT). LOCHIA CULTURE AT THE TIME OF EXAMINATION SHOWED NOTHING IN PARTICULAR.(TREATMENT WITH PICILLIBACTA). ON (B)(6) 2018 AND (B)(6) 2018 (POSTOPERATIVE DAY 5 AND 6), THE PATIENT HAD NO PYREXIA, AND HAD HEADACHE AND WOUND PAIN, WHICH WERE UNDER CONTROLLABLE LIMIT WITH ANALGESIC MEDICATION. ON (B)(6) 2018 (POSTOPERATIVE DAY 7), WBC WAS 9700, BAND + SEG WERE 78%, CRP WAS 8.989, THE PATIENT HAD PYREXIA UP TO 38.5°C EARLY IN THE AFTERNOON, AND THE PYREXIA TENDED TO RESOLVE TOWARD EVENING, BUT THE PATIENT STARTED TO HAVE TACHYCARDIA. AN ULTRASOUND SHOWED A SUSPECTED HAEMATOMA OF 3 X 2 CM IN THE VESICOUTERINE POUCH, AND AN EMERGENCY CONTRAST-ENHANCED MRI WAS PERFORMED AND A DIAGNOSIS OF VESICOUTERINE POUCH ABSCESS WAS MADE. ASPIRATION WAS DIFFICULT, AND THE TREATMENT WAS SWITCHED TO TAZOBACTAM/PIPERACILLIN (TAZ/PIPC). THE PATIENT HAD STRONG PAIN FROM THE EVENING, AND ALSO HAD CHILLS AND SHIVERING. PYREXIA UP TO 38.5°C WAS RESOLVING. ON (B)(6) 2018 (POSTOPERATIVE DAY 8), IN THE MORNING, EMERGENCY LAPAROTOMY WITH ABSCESS REMOVAL WAS PERFORMED. DURING THE SURGERY, SEROUS FLUID COLLECTION WAS NOTED IN THE SUBCUTANEOUS TISSUE, AND THE GREATER OMENTUM WAS ATTACHED TO THE VESICOUTERINE POUCH. AFTER DETACHING THE GREATER OMENTUM, SLIGHTLY HEMORRHAGIC SEROUS FLUID WAS NOTED IN THE SAME SITE, AND RESIDUAL SUBSTANCES WHICH WERE ASSUMED TO BE SOFTENED SEPRAFILM WERE NOTED, IN ACCORDANCE WITH THE CAESAREAN SECTION WOUND. IN ADDITION, WHITE MOSS WAS NOTED IN VARIOUS AREAS, AND WERE IRRIGATED AND REMOVED AS POSSIBLE. THE SUBSTANCES WHICH WERE CONSIDERED TO BE RESIDUAL SEPRAFILM WERE SENT FOR PATHOLOGICAL EXAMINATION. THE CONDITION WAS ASSUMED TO BE ASEPTIC INFLAMMATORY PROUD FLESH, AND INTRAOPERATIVE ASCITES CULTURE WAS NEGATIVE. A DRAIN WAS PLACED IN THE SAME SITE. THE PATIENT HAD NO POSTOPERATIVE FEVER. ON POSTOPERATIVE DAY 1 OF THE RE-LAPAROTOMY, THE DRAINAGE FLUID WAS 242 G AND SEROUS, WBC WAS 13300, BAND + SEG WERE 83.2%, CRP WAS 16.016, AND THE PATIENT HAD MILD ABDOMINAL TENDERNESS. ON (B)(6) 2018 (POSTOPERATIVE DAY 2), THE DRAINAGE FLUID WAS 140 G AND SEROUS. ON (B)(6) 2018 (POSTOPERATIVE DAY 3), THE DRAIN WAS REMOVED, WBC WAS 9200, BAND + SEG WERE 77.7%, CRP WAS 10.408, AND NO REMARKABLE CHANGE WAS NOTED THEREAFTER. ON (B)(6) 2018 (POSTOPERATIVE DAY 7), THE STAPLES WERE REMOVED, WBC WAS 8500, BAND + SEG WERE 74.1%, CRP WAS 2.784, AND (NO) REMARKABLE CHANGE WAS NOTED THEREAFTER. ON (B)(6) 2018 (POSTOPERATIVE DAY 8), EXAMINATIONS SHOWED NO FINDING IN PARTICULAR, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2018, PERITONITIS (CHEMICAL) AND "MILD PYREXIA BETWEEN 37°C AND 38°C FROM THE EVENING" RESOLVED. AS OF AN UNKNOWN DATE, OUTCOMES OF CHILLS, SHIVERING, STRONG PAIN, VESICOUTERINE POUCH ABSCESS, AND TACHYCARDIA WERE UNKNOWN. THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PERITONITIS (CHEMICAL) (CHEMICAL PERITONITIS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS VESICOUTERINE POUCH ABSCESS (URINARY BLADDER ABSCESS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS VESICOUTERINE POUCH ABSCESS (UTERINE ABSCESS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING (PYREXIA). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PYREXIA UP TO 38.5 DEGREE C (PYREXIA). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS TACHYCARDIA. THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS STRONG PAIN (PAIN). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS CHILLS. THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS SHIVERING (CHILLS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). RELEVANT LABORATORY TEST RESULTS INCLUDED: BODY TEMPERATURE - ON (B)(6) 2018: [BETWEEN 36°C AND 37°C DURING DAYTIME, AND BETWEEN 37°C AND 38°C FROM THE EVENING]; ON (B)(6) 2018: 38.2 CEL [AROUND NOON]; ON (B)(6) 2018: 38.5 CEL [EARLY IN THE AFTERNOON]. NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: [DIAGNOSIS OF VESICOUTERINE POUCH ABSCESS]. ULTRASOUND SCAN - ON (B)(6) 2018: [SUSPECTED HAEMATOMA OF 3 X 2 CM IN THE VESICOUTERINE POUCH]. FINAL DIAGNOSIS WAS MODERATE PERITONITIS (CHEMICAL), VESICOUTERINE POUCH ABSCESS AND VESICOUTERINE POUCH ABSCESS. THE PATIENT WAS TREATED WITH PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (TAZOPIPE). THE PATIENT OUTCOME IS REPORTED AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR PERITONITIS (CHEMICAL), AS UNKNOWN FOR VESICOUTERINE POUCH ABSCESS, AS UNKNOWN FOR VESICOUTERINE POUCH ABSCESS, AS RECOVERING / RESOLVING FOR PYREXIA UP TO 38.5 DEGREE C, AS UNKNOWN FOR TACHYCARDIA, AS UNKNOWN FOR STRONG PAIN, AS UNKNOWN FOR CHILLS, AS UNKNOWN FOR SHIVERING AND AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING. ADDITIONALLY, AT TIME OF REPORTING, THE OUTCOME OF THE PREGNANCY IS UNKNOWN. REPORTER COMMENT: PERITONITIS (CHEMICAL): THE CAUSAL RELATIONSHIP TO SEPRAFILM WAS HIGHLY PROBABLE. OTHER POSSIBLE CAUSATIVE FACTORS FOR THE ADVERSE EVENT WAS UNKNOWN. INFECTION WAS RULED OUT; HENCE THE EVENT WAS CONSIDERED TO BE CHEMICAL. OPINION ON THE ADVERSE EVENT: IT WAS PRESUMED THAT ASEPTIC INFLAMMATORY REACTION WAS ADDED TO SEPRAFILM WHICH HAD BEEN APPLIED TO THE UTERINE WOUND, AND COVERAGE BY THE GREATER OMENTUM CAUSED ABSCESS AND PROLONGED INFLAMMATORY REACTIONS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: INVESTIGATION SUMMARY (INVESTIGATION SUMMARY# (B)(4), EVENT ID: (B)(4)) WAS RECEIVED. ADDED COMPANY COMMENT AND INVESTIGATION RESULTS IN PRODUCTS FILED. AMENDMENT TO THE REPORT DATED (B)(6) 2018: DELETED MALFUNCTION INFORMATION OF THE SUSPECT DEVICE. ADDED THE SERIOUSNESS CRITERIA OF INTERVENTION REQUIRED FOR THE EVENT "PERITONITIS (CHEMICAL)". ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 BY THE PHYSICIAN: PATIENT INFORMATION WAS ADDED, CLINICAL DATA WERE ADDED, OTHER RELEVANT HISTORY WAS ADDED, CONCOMITANT DRUGS AND TREATMENT DRUGS WERE ADDED, ONSET DATE, OUTCOME, OUTCOME DATE, AND INTENSITY OF THE ADVERSE EVENT " PERITONITIS (CHEMICAL)" WERE UPDATED, AN ADVERSE EVENT "VESICOUTERINE POUCH ABSCESS" AND ALL THE SYMPTOMS WERE ADDED, REPORTER COMMENT WAS UPDATED, AND CLINICAL COURSE WAS UPDATED. AMENDMENT TO THE PREVIOUS REPORT: RACE INFORMATION WAS CHANGED.
PERITONITIS (CHEMICAL) [CHEMICAL PERITONITIS] ([LOW GRADE FEVER]); VESICOUTERINE POUCH ABSCESS [URINARY BLADDER ABSCESS] ; VESICOUTERINE POUCH ABSCESS [UTERINE ABSCESS] ([PYREXIA], [TACHYCARDIA], [PAIN], [CHILLS], [SHIVERING]). CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 31-OCT-2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM (LP) JAPAN-KAKEN LSA-PCP UNDER REFERENCE (B)(4) ON 10-JUL-2019 AND TRANSMITTED TO SANOFI. THIS CASE INVOLVES A 32 YEARS OLD FEMALE PATIENT (160 CM AND 57.8 KG) WHO EXPERIENCED PERITONITIS (CHEMICAL) AND VESICOUTERINE POUCH ABSCESS, WHILE SHE WAS TREATED WITH THE USE OF MEDICAL DEVICE CARBOXYMETHYLCELLULOSE, SODIUM HYALURONATE [SEPRAFILM]. DATA REGARDING THIS PREGNANCY WERE RECEIVED RETROSPECTIVELY, I.E. AFTER PREGNANCY OUTCOME WAS KNOWN. THE REPORTED PERITONITIS (CHEMICAL), MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING, VESICOUTERINE POUCH ABSCESS, VESICOUTERINE POUCH ABSCESS, PYREXIA UP TO 38.5 DEGREE C, TACHYCARDIA, STRONG PAIN, CHILLS AND SHIVERING OCCURRED AT UNKNOWN GESTATION PERIOD. THE DATE OF LAST MENSTRUAL PERIOD WAS NOT REPORTED. THE ESTIMATED DUE DATE WAS NOT REPORTED. THE ACTUAL DATE OF DELIVERY WAS NOT REPORTED. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING SEASONAL ALLERGY, AND BREECH DELIVERY, AND WAS NON-TOBACCO USER. NOTES: INPATIENT. CONCOMITANT MEDICATIONS INCLUDED RANITIDINE HYDROCHLORIDE (RANITIDINE [RANITIDINE HYDROCHLORIDE]) FOR PREMEDICATION; CEFMETAZOLE SODIUM (CEFMETAZOLE SODIUM) FOR PREMEDICATION; LIDOCAINE (XYLOCAINE #1) FOR PRODUCT USED FOR UNKNOWN INDICATION; AND BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE (MARCAIN + ADRENALIN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ALLERGIC PREDISPOSITION. UNDERLYING DISEASE: CHILDBIRTH. USE OF SEPRALAP: NONE CONCURRENT CONDITION BEFORE SURGERY: NONE. HISTORICAL CONDITION: NONE. DIABETES MELLITUS: NONE. PREOPERATIVE UNDERLYING DISEASE (SURGICAL INDICATION): BREECH PRESENTATION - LABOR INDUCTION. PATIENT'S CONDITION: PREOPERATIVE CONDITION: GENERALLY HEALTHY, GOOD NUTRITION STATUS, NO ANAEMIA, NO RADIOTHERAPY. LABORATORY TESTS REGARDING INFECTION AND INFLAMMATION: WBC WERE BETWEEN 17000 AND 18000), BETWEEN 11000 AND 12000, AND BETWEEN 9000 AND 10000. CRP WAS BETWEEN 9 AND 10 ((B)(6) 2018, (B)(6) 2018, (B)(6) 2018, (B)(6) 2018, (B)(6) 2018, (B)(6) 2018) ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR CAESAREAN SECTION FOR DELIVERY (URGENT), AND UNDERWENT A SURGERY (INTRAOPERATIVE HYPERTHERMIC THERAPY: NONE). FOUR SHEETS OF SEPRAFILM WERE APPLIED TO THE UTERINE WOUND AND ANTERIOR SURFACE. APPLICATION SITE OF SEPRAFILM: UTERINE WOUND AND ANTERIOR SURFACE. DIRECT APPLICATION TO THE ANASTOMOSIS SITE: NONE. CONDITION OF APPLICATION: FAVORABLE. PRE-EXISTING ADHESION: NONE, ADHESIOLYSIS: NOT PERFORMED. INTRAPERITONEAL REGION. PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE, INTRAPERITONEAL IRRIGATION: NONE. ANASTOMOSIS OF RESECTION SITE. RESECTION SITE: NONE, PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE. ANASTOMOSIS METHOD FOR THE RESECTION SITE: HAND SUTURE, INTERRUPTED ANASTOMOSIS. SUTURE: INNER LAYER, OUTER LAYER: VICRYL (ABSORBABLE, SYNTHETIC, MULTI THREAD). STATUS OF OPERATIVE FIELD: ASEPTIC (CLEAN) SURGERY. LAPAROTOMY WOUND SUTURE LAYER. LENGTH OF LAPAROTOMY INCISION: 10 CM, SUTURE LAYER: 3 LAYERS. ANASTOMOSIS METHOD FOR THE FIRST LAYER (PERITONEUM): CONTINUOUS SUTURE, SUTURE: ABSORBABLE, SYNTHETIC, MULTI THREAD (VYCRYL). ANASTOMOSIS METHOD FOR THE SKIN: HAND SUTURE, INTERRUPTED ANASTOMOSIS. ABSORBABLE, SYNTHETIC, MONO THREAD. PRE-EXISTING NON-PURULENT INFLAMMATION: NONE, PRE-EXISTING INFECTION: NONE. OPERATIVE TIME: APPROXIMATELY 39 MINUTES, HAEMORRHAGE VOLUME: 900, BLOOD TRANSFUSION: NONE. OTHER CONCOMITANTLY USED MEDICAL DEVICE: NONE. IN (B)(6) 2018, THE PATIENT RECEIVED CEFMETAZOLE AFTER THE CAESAREAN SECTION. ON (B)(6) 2018 (POSTOPERATIVE DAY 1 AFTER THE CAESAREAN SECTION), WBC WAS 17100, AND FRACTION AND CRP WERE NOT MEASURED. THE BODY TEMPERATURE WAS AROUND 36°C (36°C OR ABOVE AND BELOW 37°C) DURING DAYTIME, AND THE PATIENT PRESENTED WITH MILD PYREXIA BETWEEN 37°C AND 38°C FROM THE EVENING. AN ANALGESIC DRUG LOXOPROFEN WAS USED ON AN AS-NEEDED BASIS WHEN HAVING PAIN. THE PATIENT EXPERIENCED PERITONITIS (CHEMICAL) (CONFIRMED WITH CT SCAN) (TREATMENT: TAZOPIPE). THE EXPRESSION SITE WAS OBVIOUSLY THE SITE WHERE SEPRAFILM WAS APPLIED TO. HISTOLOGICAL EXAMINATION, IF THE EVENT WAS CONSIDERED TO BE FOREIGN BODY REACTION: INFLAMMATORY EXUDATE, CONSISTENT WITH HYALURONATE INCLUSION. SPECIMEN: ASCITES, UTERINE BLEEDING GENERAL AEROBES AND GENERAL ANAEROBES: NOT DETECTED. SURGICAL SITUATION. THE CHILD IN BREECH PRESENTATION WAS DELIVERED ROUTINELY WITH TRANSVERSE SKIN INCISION. THE FIRST LAYER OF THE MYOMETRIUM WAS ANASTOMOSED WITH INTERRUPTED SUTURES USING 0 VICRYL DETACH (PLUS), AND THE SECOND LAYER OF THE MYOMETRIUM WAS ANASTOMOSED WITH CONTINUOUS SUTURES USING 1 VICRYL. HAEMOSTASIS WAS CONFIRMED, SEROUS MEMBRANE REMAINED NONSUTURED, AND SEPRAFILM WAS APPLIED TO THE SEROUS MEMBRANE INCISION SITE. SUBSEQUENTLY, THE LAPAROTOMY WAS CLOSED WITH CONTINUOUS ANASTOMOSIS OF THE RETROPERITONEUM WITH 0 VICRYL. NO DRAIN WAS PLACED. ON (B)(6) 2018 AND (B)(6) 2018 (POSTOPERATIVE DAY 2 AND 3), THE PATIENT HAD NO PYREXIA. ON (B)(6) 2018 (POSTOPERATIVE DAY 4), WBC WAS 11200, BAND + SEG WERE 77.5%, CRP WAS 8.49. THE BODY TEMPERATURE WAS 38.2°C AT AROUND NOON, AND THE PATIENT HAD CHILLS. SUBSEQUENTLY, THE PYREXIA TENDED TO RESOLVE TOWARD EVENING. THE PATIENT STARTED TO RECEIVE AN IRON PREPARATION FERROMIA, AND EXAMINATION SHOWED A HAEMATOMA IN THE UTERINE WOUND ON ULTRASOUND. ANTIBIOTIC THERAPY WAS CONTINUED, AND CHANGED TO AMPICILLIN/SULBACTAM (ABPC/SBT). LOCHIA CULTURE AT THE TIME OF EXAMINATION SHOWED NOTHING IN PARTICULAR.(TREATMENT WITH PICILLIBACTA). ON (B)(6) 2018 AND (B)(6) 2018 (POSTOPERATIVE DAY 5 AND 6), THE PATIENT HAD NO PYREXIA, AND HAD HEADACHE AND WOUND PAIN, WHICH WERE UNDER CONTROLLABLE LIMIT WITH ANALGESIC MEDICATION. ON (B)(6) 2018 (POSTOPERATIVE DAY 7), WBC WAS 9700, BAND + SEG WERE 78%, CRP WAS 8.989, THE PATIENT HAD PYREXIA UP TO 38.5°C EARLY IN THE AFTERNOON, AND THE PYREXIA TENDED TO RESOLVE TOWARD EVENING, BUT THE PATIENT STARTED TO HAVE TACHYCARDIA. AN ULTRASOUND SHOWED A SUSPECTED HAEMATOMA OF 3 X 2 CM IN THE VESICOUTERINE POUCH, AND AN EMERGENCY CONTRAST-ENHANCED MRI WAS PERFORMED AND A DIAGNOSIS OF VESICOUTERINE POUCH ABSCESS WAS MADE. ASPIRATION WAS DIFFICULT, AND THE TREATMENT WAS SWITCHED TO TAZOBACTAM/PIPERACILLIN (TAZ/PIPC). THE PATIENT HAD STRONG PAIN FROM THE EVENING, AND ALSO HAD CHILLS AND SHIVERING. PYREXIA UP TO 38.5°C WAS RESOLVING. ON (B)(6) 2018 (POSTOPERATIVE DAY 8), IN THE MORNING, EMERGENCY LAPAROTOMY WITH ABSCESS REMOVAL WAS PERFORMED. DURING THE SURGERY, SEROUS FLUID COLLECTION WAS NOTED IN THE SUBCUTANEOUS TISSUE, AND THE GREATER OMENTUM WAS ATTACHED TO THE VESICOUTERINE POUCH. AFTER DETACHING THE GREATER OMENTUM, SLIGHTLY HEMORRHAGIC SEROUS FLUID WAS NOTED IN THE SAME SITE, AND RESIDUAL SUBSTANCES WHICH WERE ASSUMED TO BE SOFTENED SEPRAFILM WERE NOTED, IN ACCORDANCE WITH THE CAESAREAN SECTION WOUND. IN ADDITION, WHITE MOSS WAS NOTED IN VARIOUS AREAS, AND WERE IRRIGATED AND REMOVED AS POSSIBLE. THE SUBSTANCES WHICH WERE CONSIDERED TO BE RESIDUAL SEPRAFILM WERE SENT FOR PATHOLOGICAL EXAMINATION. -> THE CONDITION WAS ASSUMED TO BE ASEPTIC INFLAMMATORY PROUD FLESH, AND INTRAOPERATIVE ASCITES CULTURE WAS NEGATIVE. A DRAIN WAS PLACED IN THE SAME SITE. THE PATIENT HAD NO POSTOPERATIVE FEVER. ON POSTOPERATIVE DAY 1 OF THE RE-LAPAROTOMY, THE DRAINAGE FLUID WAS 242 G AND SEROUS, WBC WAS 13300, BAND + SEG WERE 83.2%, CRP WAS 16.016, AND THE PATIENT HAD MILD ABDOMINAL TENDERNESS. ON (B)(6) 2018 (POSTOPERATIVE DAY 2), THE DRAINAGE FLUID WAS 140 G AND SEROUS. ON (B)(6) 2018 (POSTOPERATIVE DAY 3), THE DRAIN WAS REMOVED, WBC WAS 9200, BAND + SEG WERE 77.7%, CRP WAS 10.408, AND NO REMARKABLE CHANGE WAS NOTED THEREAFTER. ON (B)(6) 2018 (POSTOPERATIVE DAY 7), THE STAPLES WERE REMOVED, WBC WAS 8500, BAND + SEG WERE 74.1%, CRP WAS 2.784, AND (NO) REMARKABLE CHANGE WAS NOTED THEREAFTER. ON (B)(6) 2018 (POSTOPERATIVE DAY 8), EXAMINATIONS SHOWED NO FINDING IN PARTICULAR, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2018, PERITONITIS (CHEMICAL), "MILD PYREXIA BETWEEN 37°C AND 38°C FROM THE EVENING", AND VESICOUTERINE POUCH ABSCESS RESOLVED. AS OF AN UNKNOWN DATE, OUTCOMES OF CHILLS, SHIVERING, STRONG PAIN, AND TACHYCARDIA WERE UNKNOWN. THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PERITONITIS (CHEMICAL) (CHEMICAL PERITONITIS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS VESICOUTERINE POUCH ABSCESS (URINARY BLADDER ABSCESS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS VESICOUTERINE POUCH ABSCESS (UTERINE ABSCESS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING (PYREXIA). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PYREXIA UP TO 38.5 DEGREE C (PYREXIA). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS TACHYCARDIA. THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS STRONG PAIN (PAIN). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS CHILLS. THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). THE PATIENT DEVELOPED AN EVENT OF A SERIOUS SHIVERING (CHILLS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. DUE TO THIS EVENT PATIENT'S HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 (HOSPITALIZATION DURING 16 DAYS). RELEVANT LABORATORY TEST RESULTS INCLUDED: BODY TEMPERATURE - ON (B)(6) 2018: [BETWEEN 36°C AND 37°C DURING DAYTIME, AND BETWEEN 37°C AND 38°C FROM THE EVENING]; ON (B)(6) 2018: 38.2 CEL [AROUND NOON]; ON (B)(6) 2018: 38.5 CEL [EARLY IN THE AFTERNOON]. NUCLEAR MAGNETIC RESONANCE IMAGING - ON (B)(6) 2018: [DIAGNOSIS OF VESICOUTERINE POUCH ABSCESS] ULTRASOUND SCAN - ON (B)(6) 2018: [SUSPECTED HAEMATOMA OF 3 X 2 CM IN THE VESICOUTERINE POUCH]. FINAL DIAGNOSIS WAS MODERATE PERITONITIS (CHEMICAL) AND MODERATE VESICOUTERINE POUCH ABSCESS. THE PATIENT WAS TREATED WITH AMPICILLIN SODIUM, SULBACTAM SODIUM (PICILLIBACTA) AND PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (TAZOPIPE). THE PATIENT OUTCOME IS REPORTED AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR PERITONITIS (CHEMICAL), AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR VESICOUTERINE POUCH ABSCESS, AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR VESICOUTERINE POUCH ABSCESS, AS RECOVERING / RESOLVING FOR PYREXIA UP TO 38.5 DEGREE C, AS UNKNOWN FOR TACHYCARDIA, AS UNKNOWN FOR STRONG PAIN, AS UNKNOWN FOR CHILLS, AS UNKNOWN FOR SHIVERING AND AS RECOVERED / RESOLVED ON (B)(6) 2018 FOR MILD PYREXIA BETWEEN 37 AND 38 DEGREES C FROM THE EVENING. ADDITIONALLY, AT TIME OF REPORTING, THE OUTCOME OF THE PREGNANCY IS UNKNOWN. REPORTER COMMENT: PERITONITIS (CHEMICAL): THE CAUSAL RELATIONSHIP TO SEPRAFILM WAS HIGHLY PROBABLE. OTHER POSSIBLE CAUSATIVE FACTORS FOR THE ADVERSE EVENT WERE UNKNOWN. INFECTION WAS RULED OUT; HENCE THE EVENT WAS CONSIDERED TO BE CHEMICAL. OPINION ON THE ADVERSE EVENT: IT WAS PRESUMED THAT ASEPTIC INFLAMMATORY REACTION WAS ADDED TO SEPRAFILM WHICH HAD BEEN APPLIED TO THE UTERINE WOUND, AND COVERAGE BY THE GREATER OMENTUM CAUSED ABSCESS AND PROLONGED INFLAMMATORY REACTIONS. VESICOUTERINE POUCH ABSCESS: THE CAUSAL RELATIONSHIP TO SEPRAFILM WAS HIGHLY PROBABLE. OTHER POSSIBLE CAUSATIVE FACTORS FOR THE ADVERSE EVENT WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: INVESTIGATION SUMMARY (INVESTIGATION SUMMARY#(B)(4) , EVENT ID: (B)(6)) WAS RECEIVED. ADDED COMPANY COMMENT AND INVESTIGATION RESULTS IN PRODUCTS FILED. AMENDMENT TO THE REPORT DATED (B)(6) 2018: DELETED MALFUNCTION INFORMATION OF THE SUSPECT DEVICE. ADDED THE SERIOUSNESS CRITERIA OF INTERVENTION REQUIRED FOR THE EVENT "PERITONITIS (CHEMICAL)". ADDITIONAL INFORMATION WAS RECEIVED ON 10-JUN-2019 BY THE PHYSICIAN: PATIENT INFORMATION WAS ADDED, CLINICAL DATA WERE ADDED, OTHER RELEVANT HISTORY WAS ADDED, CONCOMITANT DRUGS AND TREATMENT DRUGS WERE ADDED, ONSET DATE, OUTCOME, OUTCOME DATE, AND INTENSITY OF THE ADVERSE EVENT " PERITONITIS (CHEMICAL)" WERE UPDATED, AN ADVERSE EVENT "VESICOUTERINE POUCH ABSCESS" AND ALL THE SYMPTOMS WERE ADDED, REPORTER COMMENT WAS UPDATED, AND CLINICAL COURSE WAS UPDATED. AMENDMENT TO THE PREVIOUS REPORT: RACE INFORMATION WAS CHANGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10-JUL-2019 FROM THE PHYSICIAN: UPDATED OUTCOME DATE, OUTCOME, AND INTENSITY OF THE EVENT "VESICOUTERINE POUCH ABSCESS"; AND UPDATED CLINICAL COURSE AND REPORTER COMMENT.
PERITONITIS (CHEMICAL) [CHEMICAL PERITONITIS] CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 31-OCT-2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM JAPAN_OTHER SANOFI-JAPAN GROUP EMPLOYEE UNDER REFERENCE (B)(4). ON AND TRANSMITTED TO SANOFI. THIS CASE INVOLVES A 31 YEARS OLD FEMALE PATIENT WHO EXPERIENCED PERITONITIS (CHEMICAL), WHILE SHE USING WITH THE USE OF MEDICAL DEVICE CARBOXYMETHYLCELLULOSE, SODIUM HYALURONATE [SEPRAFILM]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2018, A SHEET OF SEPRAFILM WAS APPLIED TO THE PATIENT´S SUTURE SITE OF THE WOMB, THE CAVUM VESICOUTERINUM, DURING CAESAREAN SECTION FOR DELIVERY (URGENT). ON (B)(6) 2018, THE PATIENT EXPERIENCED PERITONITIS (CHEMICAL). THE EXPRESSION SITE WAS OBVIOUSLY THE SITE WHERE SEPRAFILM WAS APPLIED TO. THE OUTCOME OF PERITONITIS (CHEMICAL) WAS "NOT RESOLVED". THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PERITONITIS (CHEMICAL) (CHEMICAL PERITONITIS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT AND WAS LEADING TO INTERVENTION. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. FINAL DIAGNOSIS WAS SEVERE PERITONITIS (CHEMICAL). IT WAS NOT REPORTED IF THE PATIENT RECEIVED A CORRECTIVE TREATMENT. THE PATIENT OUTCOME IS REPORTED AS NOT RECOVERED / NOT RESOLVED ON AN UNKNOWN DATE FOR PERITONITIS (CHEMICAL). REPORTER COMMENT: IT WAS PLAUSIBLE THAT SEPRAFILM WAS RELATED TO PERITONITIS (CHEMICAL). ANOTHER FACTOR SUSPECTED OF CAUSING PERITONITIS (CHEMICAL) WAS THE PATIENT´S ALLERGIC PREDISPOSITION. INFECTION WAS RULED OUT; HENCE THE EVENT WAS CONSIDERED TO BE CHEMICAL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: INVESTIGATION SUMMARY (INVESTIGATION SUMMARY#208153, EVENT ID: (B)(4) WAS RECEIVED. ADDED COMPANY COMMENT AND INVESTIGATION RESULTS IN PRODUCTS FILED. AMENDMENT TO THE REPORT DATED (B)(6) 20182018: DELETED MALFUNCTION INFORMATION OF THE SUSPECT DEVICE. ADDED THE SERIOUSNESS CRITERIA OF INTERVENTION REQUIRED FOR THE EVENT "PERITONITIS (CHEMICAL)".
PERITONITIS (CHEMICAL) [CHEMICAL PERITONITIS]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON (B)(6) 2018 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM (B)(4)_OTHER SANOFI-(B)(4) GROUP EMPLOYEE UNDER REFERENCE (B)(4) ON AND TRANSMITTED TO SANOFI. THIS CASE INVOLVES A (B)(6) YEARS OLD FEMALE PATIENT WHO EXPERIENCED PERITONITIS (CHEMICAL), WHILE SHE USING WITH THE USE OF MEDICAL DEVICE CARBOXYMETHYLCELLULOSE, SODIUM HYALURONATE [SEPRAFILM]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON (B)(6) 2018, A SHEET OF SEPRAFILM WAS APPLIED TO THE PATIENT´S SUTURE SITE OF THE WOMB, THE CAVUM VESICOUTERINUM, DURING CAESAREAN SECTION FOR DELIVERY (URGENT). ON (B)(6) 2018, THE PATIENT EXPERIENCED PERITONITIS (CHEMICAL). THE EXPRESSION SITE WAS OBVIOUSLY THE SITE WHERE SEPRAFILM WAS APPLIED TO. THE OUTCOME OF PERITONITIS (CHEMICAL) WAS "NOT RESOLVED". THE PATIENT DEVELOPED AN EVENT OF A SERIOUS PERITONITIS (CHEMICAL) (CHEMICAL PERITONITIS). THIS EVENT WAS ASSESSED AS MEDICALLY SIGNIFICANT. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. FINAL DIAGNOSIS WAS SEVERE PERITONITIS (CHEMICAL). IT WAS NOT REPORTED IF THE PATIENT RECEIVED A CORRECTIVE TREATMENT. THE PATIENT OUTCOME IS REPORTED AS NOT RECOVERED / NOT RESOLVED ON AN UNKNOWN DATE FOR PERITONITIS (CHEMICAL). REPORTER COMMENT: IT WAS PLAUSIBLE THAT SEPRAFILM WAS RELATED TO PERITONITIS (CHEMICAL). ANOTHER FACTOR SUSPECTED OF CAUSING PERITONITIS (CHEMICAL) WAS THE PATIENT´S ALLERGIC PREDISPOSITION. INFECTION WAS RULED OUT; HENCE THE EVENT WAS CONSIDERED TO BE CHEMICAL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: INVESTIGATION SUMMARY (INVESTIGATION SUMMARY#(B)(4), EVENT ID: (B)(6)) WAS RECEIVED. ADDED COMPANY COMMENT AND INVESTIGATION RESULTS IN PRODUCTS FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032793 | SEPRAFILM | MCN | MCN | GENZYME CORPORATION(FRAMINGHAM) | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization| O| R | CEFMETAZOLE SODIUM,INTRAVENOUS INFUSION.| CEFMETAZOLE SODIUM,INTRAVENOUS INFUSION.| MARCAIN + ADRENALIN,UNKNOWN.| MARCAIN + ADRENALIN,UNKNOWN.| RANITIDINE [RANITIDINE HYDROCHLORIDE],INTRAVENOUS.| RANITIDINE [RANITIDINE HYDROCHLORIDE],INTRAVENOUS.| XYLOCAINE #1 (LIDOCAINE),UNKNOWN.| XYLOCAINE #1 (LIDOCAINE),UNKNOWN. |