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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN
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GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Fever (1858); Peritonitis (2252); Abdominal Distention (2601)
Event Date 04/16/2019
Event Type  Injury  
Event Description
Peritonitis [peritonitis].Case narrative: initial information received on 11-sep-2019 regarding an unsolicited valid serious case received from (b)(6)-pcp under reference on 11-sep-2019 and transmitted to sanofi.This case involves a (b)(6) female patient who experienced peritonitis, 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.Underlying disease: none.Concurrent disease: none.Medical history: none.On (b)(6) 2019, 10-12 hours after membrane rupture, caesarean section was performed.Seprafilm (number of sheet used: 1 pack) was attached to the uterine corpus.Application site: uterine corpus, under the incision.On (b)(6) 2019, the course was favorable until the 4th day after surgery.On (b)(6) 2019, peritonitis developed.At 5 days after surgery, bloating developed.On (b)(6) 2019, at 6 days after surgery, pyrexia developed.On (b)(6) 2019, at 8 days after surgery, the patient was transported to a nearby hospital (hospital a).Thereafter, antibiotic therapy was given for a few days, but no improvement was seen.Laparotomy revealed adhesions.Appendicectomy and resection of the sigmoid anastomotic site were performed.The patient was diagnosed with peritonitis by the physician.Relationship between onset site and application site: unknown bacterial culture: staphylococcus aureus+, gardnerella vaginalis+ on an unknown date, the peritonitis resolved.The patient developed an event of a serious peritonitis.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: bacterial test on an unknown date: [staphylococcus aureus+, gardnerella vaginalis+] final diagnosis was severe peritonitis.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on an unknown date for peritonitis.Reporter comment: causality between seprafilm and peritonitis: unknown.The peritonitis occurred due to the patient's idiosyncratic reaction.Additional information was received on 23-sep-2019: received investigation summary (investigation summary #(b)(6), event id: (b)(6); and added reporter information and company comment.
 
Event Description
Peritonitis.Case narrative: initial information received on 11-sep-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 24-oct-2019 and transmitted to sanofi.This case involves a 33 years old female patient (160 cm and 58 kg) who experienced peritonitis, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis 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 is (b)(6) 2019.The patient's past medical history included placental insufficiency and premature rupture of membranes.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient was non-tobacco user.Notes: inpatient.Concurrent disease: none.Medical history: none.Complication prior to surgery: none.Diabetes mellitus: no.Allergic factor: none.Patient background: pregnant housewife.Concomitant medications included cefotiam hydrochloride (cefapicol) for infection prophylaxis; and ceftriaxone sodium (rocephin) for infection prophylaxis.On an unknown date, the patient's status before surgery was as follows: underlying disease: fetoplacental insufficiency, condition before surgery: generally healthy, nutritional condition: good, anemia: no, radiotherapy: none on (b)(6) 2019, with premature rupture of membranes at 40 weeks and 6 days of pregnancy, due to fetoplacental insufficiency, abdominal cesarean section was performed 10-12 hours after membrane rupture.Seprafilm (number of sheet used: 1 pack) was attached to the uterine corpus.Seprafilm was attached to the entire wound.Application site: anterior and lower part of the uterus (wound), infection in application site: none, direct application to anastomosis site: yes, site: anterior and lower part of the uterus (wound), number of sheets: whole, condition of placement: favorable, the operating surgeon's experience in using seprafilm: multiple cases.Placement site of drain: none, number of uterine incision: 0.Pre-existing adhesion: none.Intra-abdominal cavity: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: no.Anastomosis of resection site: resection site: none, pre-existing non-purulent inflammation: none, pre-existing infection: none, anastomosis method of resection site: hand suture (continuous), suture thread (type): absorbable.Operative field: clean-contaminated operation.Suture of abdominal incision: length of laparotomy incision: 12 cm, suture layer: 2 layers, suture method of the 1st layer (peritoneum layer): continuous, suture thread: absorbable, method of skin suture: skin stapler, pre-existing non-purulent inflammation: none.Operation time: about 35 minutes, volume of haemorrhage: 900 g, blood transfusion: none after surgery: other medical device used: none, second look laparoscopy: none.On (b)(6) 2019, the patient was noted to have wbc of 22900.On (b)(6) 2019, the patient was noted to have wbc of 13500 and crp of 25.1.On (b)(6) 2019, the course was favorable until the 4th day after surgery.The patient was noted to have wbc of 10000 and crp of 18.2.On (b)(6) 2019, the patient was noted to have wbc of 20300, crp of 22.3, and pyrexia.Peritonitis developed.On the 5th day after surgery, bloating developed.On (b)(6) 2019, on the 6th day after surgery, pyrexia developed.On (b)(6) 2019, the patient was noted to have wbc of 21500, crp of 18.3, and pyrexia.The patient was given referral letter to hospital a (gynecology and obstetrics department).On (b)(6) 2019, on the 8th day after surgery, the patient was transported to a nearby hospital (hospital a).The patient was diagnosed with peritonitis.After diagnosis of peritonitis, laparotomy was performed again.Without improvement despite antibiotic therapy for a few days, the laparotomy revealed adhesions.Appendicectomy, drain insertion, and resection of anastomosis site of the sigmoid colon (at a surgery department) were performed.Positional relationship between onset site and application site: unknown.Bacterial culture: staphylococcus aureus+, gardnerella vaginalis+.On an unknown date, the peritonitis resolved.The patient developed an event of a serious 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) 2019 (hospitalization during 8 days).Relevant laboratory test results included: bacterial test - on an unknown date: [staphylococcus aureus+, gardnerella vaginalis+] c-reactive protein - on (b)(6) 2019: 25.1; on (b)(6) 2019: 18.2; on (b)(6) 2019: 22.3; on (b)(6) 2019: 18.3.White blood cell count - on (b)(6) 2019: 22900; on (b)(6) 2019: 13500; on (b)(6) 2019: 10000; on (b)(6) 2019: 20300; on (b)(6) 2019: 21500.Final diagnosis was severe peritonitis.An unknown corrective treatment was received.The patient outcome is reported as recovered / resolved on an unknown date for peritonitis.Additionally, at time of reporting, the patient delivered 2 babies on (b)(6) 2019 (delivery type: cesarean).Outcome of the pregnancy was reported as full-term.Reporter comment: [peritonitis] causality between seprafilm and peritonitis: unknown.The peritonitis occurred due to the patient's idiosyncrasy.Possible causative factor for the event other than seprafilm: unknown.Until this time, the reporter had experiences of using seprafilm in many cases mainly after caesarean section and having favorable courses.Thus, it was unknown whether seprafilm was the cause of the post-operational peritonitis.Post-operational peritonitis is a complication that could occur after caesarean section at a constant rate.Additional information was received on 23-sep-2019: received investigation summary (investigation summary #221084, event id: 60272); and added reporter information and company comment.Additional information was received on 24-oct-2019 from the physician: updated patient information and patient details; added other relevant history, laboratory data, and details of hospitalization; and updated reporter comment and clinical course.
 
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Brand Name
SEPRAFILM
Type of Device
MCN
Manufacturer (Section D)
GENZYME CORPORATION(FRAMINGHAM)
76 new york avenue
framingham 01701
MDR Report Key9124176
MDR Text Key165548768
Report Number1220423-2019-00023
Device Sequence Number1
Product Code MCN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Lot NumberASKU
Patient Sequence Number1
Treatment
CEFAPICOL (CEFOTIAM HYDROCHLORIDE),UNKNOWN; ROCEPHIN (CEFTRIAXONE SODIUM),UNKNOWN
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age33 YR
Patient Weight58
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