MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)

Patient Problems Abscess (1690); Bacterial Infection (1735); Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 05/15/2019

Event Type  Injury  

Event Description

Abscess [abscess].Case narrative: initial information received on 23-jan-2020 regarding an unsolicited valid serious case received from (b)(6)-pcp under reference on 23-jan-2020 and transmitted to sanofi.This case is linked to cases (b)(4).This case involves a (b)(6) years old female patient who experienced abscess, 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.At the time of the event, the patient had ongoing uterine leiomyoma.Underlying disease: uterine myoma.History of pregnancy and giving birth: pregnancy, 2 times; birth, 1 time.On an unknown date, the patient underwent bilateral hysterosalpingectomy for uterine myoma with hypermenorrhea that had required blood transfusion, and one sheet of seprafilm (lot #, unknown) cut into 6 pieces was applied to the pelvic floor and the vaginal stump.On an unknown date, on the 6th postoperative day, the patient was discharged from the hospital.Within the day, the patient was seen at the emergency outpatient department for abdominal pain and vomiting and was diagnosed as having paralytic ileus due to a postoperative abscess in the vaginal stump (it was unknown if the abscess site duplicated the seprafilm applied site).The stump was transvaginally opened and irrigated, and antibiotic administration was started.On an unknown date, the symptom improved, and the irrigation was decided to be continued on an outpatient basis.The patient was discharged from the hospital on the 16th postoperative day.On an unknown date, at the outpatient visit on the 26th postoperative day, a foreign substance (a piece of plastic) was exposed at the vaginal stump, and was pulled and extracted.The piece of plastic, which seprafilm was apparently to be sealed with, probably came to be slipped in when seprafilm was cut at the surgery.On an unknown date, the outcome of abscess was unknown.The patient developed an event of a serious abscess.This event was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: body temperature - on an unknown date: 37.1 cel.C-reactive protein - on an unknown date: 23.3 mg/dl.White blood cell count - on an unknown date: 13400 /ul.Final diagnosis was abscess.An unknown corrective treatment was received.The patient outcome is reported as unknown for abscess.Reporter comment: causal role of seprafilm in the event "abscess": unknown.A cause of the event was considered to be the contamination with the piece of plastic.

Event Description

Abscess [abscess].Case narrative: initial information received on 23-jan-2020 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 12-mar-2020 and transmitted to sanofi.This case is linked to cases (b)(4), (b)(4) and (b)(4).This case involves a 48 years old female patient who experienced abscess, 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.At the time of the event, the patient had ongoing uterine leiomyoma.Underlying disease: uterine myoma.History of pregnancy and giving birth: pregnancy, 2 times; birth, 1 time.On (b)(6) 2019, the patient underwent bilateral hysterosalpingectomy for uterine myoma with hypermenorrhea that had required blood transfusion, and one sheet of seprafilm (lot #, unknown) cut into 6 pieces was applied to the pelvic floor and the vaginal stump.On (b)(6) 2019, on the 6th postoperative day, the patient was discharged from the hospital.Within the day, the patient was seen at the emergency outpatient department for abdominal pain and vomiting and was diagnosed as having paralytic ileus due to a postoperative abscess in the vaginal stump (it was unknown if the abscess site duplicated the seprafilm applied site).The stump was transvaginally opened and irrigated, and antibiotic administration was started.On (b)(6) 2019, the symptom improved, and the irrigation was decided to be continued on an outpatient basis.The patient was discharged from the hospital on the 16th postoperative day.On (b)(6) 2019, at the outpatient visit on the 26th postoperative day, a foreign substance (a piece of plastic) was exposed at the vaginal stump, and was pulled and extracted.The piece of plastic, which seprafilm was apparently to be sealed with, probably came to be slipped in when seprafilm was cut at the surgery.On an unknown date, the outcome of abscess was unknown.The patient developed an event of a serious abscess.This event was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: body temperature - on an unknown date: 37.1 cel; c-reactive protein - on an unknown date: 23.3 mg/dl; white blood cell count - on an unknown date: 13400 /ul.Final diagnosis was abscess.An unknown corrective treatment was received.The patient outcome is reported as unknown for abscess.Reporter comment: causal role of seprafilm in the event "abscess": unknown a cause of the event was considered to be the contamination with the piece of plastic.Additional information was received on 12-mar-2020 from the healthcare professional: added onset date of the event and updated clinical course.Local comments: *downgrade*.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 9659893
• MDR Text Key: 192074125
• Report Number: 1220423-2020-00004
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR