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Foreign body reaction [foreign body reaction].Case narrative: initial information received on 07-aug-2018 regarding an unsolicited valid serious case received from (b)(6) under reference (b)(4) and transmitted to sanofi.This case involves a (b)(6) female patient (161 cm and (b)(6)) who experienced foreign body reaction, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].Data regarding this pregnancy were received prospectively, i.E.Before pregnancy outcome was known.The reported foreign body reaction 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) 2017.It was a multiple pregnancy.The patient's past medical history included twin pregnancy and caesarean section on (b)(6) 2017.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 non-tobacco user.On (b)(6) 2017, the patient was admitted.On (b)(6) 2017, during an elective caesarean operation by hysterotomy, 1 sheet of seprafilm (carboxymethylcellulose, sodium hyaluronate) was placed under rectus abdominis fascia.Details of the operation, incision wound, and seprafilm use were reported as follows: intraoperative heat therapy: no.Direct placement on anastomotic site: no.Condition of placement: favorable.Infection at the application site: none.Operating surgeon's experience with the use of seprafilm: yes (details unknown).Indwelling drain: none.Incision: transverse pfannenstiel incision of the lower uterine segment.Seprafilm: placed under fascia after suturing.Cyst formation at the placement site was noted later.Preexisting adhesions in the abdominal cavity: none.Preexisting nonpurulent inflammation in the abdominal cavity: none.Preexisting infection in the abdominal cavity: none.Irrigation in the abdominal cavity: no.Resection: none.State of surgical field: clean-contaminated.Length of laparotomy incision: 14 cm.Suturing method for the first layer (peritoneum): continuous manual suturing with synthetic absorbable thread (polysorb).Suturing method for skin: continuous manual suturing with monodiox thread.Duration of the operation: approx.One hour.Volume of haemorrhage: 2550 (including amniotic fluid).Blood infusion: not performed.Details of the postoperative findings were reported as follows: combined use medical device: none.Second look laparoscopy: no.On (b)(6) 2017, a foreign body reaction (moderate) was noted at the site of the uterine wound under the rectus abdominis fascia.Details of this event were reported as follows; event detection method: blood test.Severity: moderate.Tissue examination: not performed.Prolonged hospitalization: yes.Re-hospitalization for treatment: no.Infection was suspected, and cefmetazole (cmz) was administered prophylactically.On (b)(6) 2017, body temperature was 39.4 degrees c.Abdominal pain was present.Bacterial culture was performed (with serum [blood, urine and lochia]), which gave negative result.A blood test was also performed to find infection and inflammation statuses (wbc, 21400/mm3; crp, 26.31; neut 89.6%).Ct (e) detected 16 mm cyst in the lower umbilical region of abdominal cavity (exactly where seprafilm was placed).As cmz did not work, the medication was switched to doripenem (drpm).On (b)(6) 2017, drainage was performed.Retention of odorless, blown serum was noted (collected for culture test).Relaparotomy was performed.Seprafilm could not be located.Other measures taken included an irrigation of abdominal wall cyst.After the relaparotomy, marked improvement in the state of the event was observed.On (b)(6) 2017, drpm was switched to taz/pipc (tazobactam sodium and piperacillin sodium), as drpm did not work.On (b)(6) 2017, the fever showed a tendency toward alleviation, but abdominal pain was marked.Wbc was 19000 mm3, and crp was 29.3.Blood and urine were collected for culture test.Ct (e) showed marked ascites as well as cyst in uterine wound (exactly where seprafilm was placed).On (b)(6) 2017, the patient was discharged at her request, although abdominal pain was still present.About 24 days were required for symptomatic relief.On (b)(6) 2017, the event resolved.The patient developed an event of a serious foreign body reaction.Due to this event patient's hospitalization was prolonged.The patient was discharged on (b)(6) 2017 (hospitalization during 18 days).Relevant laboratory test results included: (b)(6).Final diagnosis was foreign body reaction.The patient was treated with doripenem (doripenem), cefmetazole sodium (cefmetazole sodium) and piperacillin sodium, tazobactam sodium (tazobactam sodium and piperacillin sodium).The patient outcome is reported as recovered / resolved on (b)(6) 2017 for foreign body reaction.Additionally, at time of reporting, the patient delivered 2 babies on (b)(6) 2017 (delivery type: cesarean).Outcome of the pregnancy was reported as unknown and fetal outcome was reported as unknown.Reporter comment: the causal relationship with seprafilm was probable.Reporter comment (added on 29-aug-2018): all culture tests did not detect any causative bacteria, and the possibility of infection was low.The area of pain and swelling coincided with the seprafilm placement site.Irrigation and drainage resulted in swift alleviation of pain and swelling in the abdominal wall cyst.Based on the above-mentioned facts, seprafilm was strongly suspected of having induced the event "foreign body reaction." additional information was received on 29-aug-2018 from the physician: updated patient information (date of birth, height, weight), updated event information (dates of admission and discharge, treatment details), updated clinical course, added reporter comment, added lab data, and added corrective treatment.Investigation summary was received on 17-sep-2018 ((b)(4)): added company comment.
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