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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735); Fever (1858)

Event Date 05/10/2019

Event Type  Injury  

Event Description

Abscess [abscess] ([pyrexia]).Case narrative: initial information received on 13-may-2019 regarding an unsolicited valid serious case received from (lp) (b)(6) under reference (b)(4) on 29-jul-2019 and transmitted to sanofi.This case involves a 45 years old female patient (159 cm and 57 kg) who experienced abscess, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included caesarean section in 2002.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing uterine leiomyoma and allergy to chemicals, and was non-tobacco user.Notes: inpatient.Underlying disease: multiple uterine myomata.Pre-operative complication: none.Diabetes mellitus: no.Pre-operative condition of the patient: generally healthy with good nutrition and with no anemia, no experience of radiotherapy.Concomitant medications included cefazolin sodium (cefazolin na) for infection prophylaxis.On (b)(6) 2019, the patient was hospitalized with multiple uterine myomata.On (b)(6) 2019, the patient underwent the following surgery: operative procedure: robotic-assisted total hysterectomy.Number of used sheet of seprafilm: 1.Application site: vaginal stump.Infection at the application site: no.Direct application to the anastomosis part: no.Condition of the application: favorable.The operator's experience in using seprafilm: this case was the 50th case.Operation details: seprafilm was applied to peritoneal defect.Drain type: vaginal stump.Existing adhesion: yes (bladder).Existing exfoliation: yes.Abdominal cavity conditions: neither non-purulent inflammation nor infection existed.Intraperitoneal lavage was practiced (0.5 l).Anastomosis of the resected parts: resected parts: yes; neither non-purulent inflammation nor infection existed.Anastomosis procedure was performed manually (running suture) with the use of absorbable suture.Operation area condition: clean-contaminated operation.Surgery time: 1.42 hours.Amount of bleeding: 10 g.Blood infusion: no.Concomitant medical device: closed drain (placed on (b)(6) and removed on (b)(6)).Drainage condition: favorable.Second look laparoscopy: no.Use of sepralap: no.On (b)(6) 2019, the patient was discharged.On 10-may-2019, the patient had pyrexia, and abscess developed, which was confirmed by ct (4.1 x 4.0 x 5.8 cm).Bacterial culture was performed with sample of vaginal discharge (sample collection date: (b)(6) 2019) for escherichia coli, and enterococcus faecalis was detected.Wbc and crp were 16500 and 14.26, respectively.Tissue examination in case of diagnosis of foreign-body reaction was not performed.The patient was receiving inpatient treatment including antibiotic therapy with unasyn for the event of abscess.Relaparotomy was not performed.Onset site was vaginal stump.On (b)(6) 2019, wbc and crp were 7400 and 0.22, respectively.On (b)(6) 2019, improvement was seen in the symptom, and the patient was discharged.On (b)(6) 2019, abscess and pyrexia resolved.The patient developed an event of a serious abscess.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2019 (hospitalization during 12 days).The patient developed an event of a serious pyrexia.The patient was hospitalized on the same day this event occurred.The patient was discharged on (b)(6) 2019 (hospitalization during 12 days).Relevant laboratory test results included: c-reactive protein - on 10-may-2019: 14.26 [14.26]; on (b)(6) 2019: 0.22 [0.22].Computerised tomogram - on 10-may-2019: [ct: stump abscess (4.1 x 4.0 x 5.8 cm)].White blood cell count - on 10-may-2019: 16500 [16500]; on (b)(6) 2019: 7400 [7400].Final diagnosis was moderate abscess.The patient was treated with sultamicillin tosilate (unasyn [sultamicillin tosilate]).The patient outcome is reported as recovered / resolved on (b)(6) 2019 for abscess and as recovered / resolved on (b)(6) 2019 for pyrexia.Reporter comment: causal relationship between seprafilm and abscess: unknown alternative etiology for abscess: operative stress, concomitant drug, concomitant medical device: suture of the vaginal stump site.Comment from the relevant physician, pharmacist, etc.: abscess developed at the suture site of the vaginal stump, in which site abscess was easy to develop.Therefore, it is unknown if it can be said that abscess was caused by seprafilm.Additional information was received on 10-jun-2019: received investigation summary (investigation summary # (b)(4), event id: (b)(4)).Additional information was received on 29-jul-2019 from the physician: added relevant history, lab data, a concomitant drug, and a treatment drug; changed onset date, outcome date, and outcome, and added a symptom (pyrexia) of the event "abscess"; and updated clinical course and reporter comment.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8903581
• MDR Text Key: 155950209
• Report Number: 1220423-2019-00013
• 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
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57