|
Abscess (application site) [abscess] ([abdominal pain], [pyrexia]) case narrative: initial information received on 03-sep-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4).On (b)(6) 2019and transmitted to sanofi.This case involves a 53 years old female patient (158 cm and 53.9 kg) who experienced abscess (application site), while she was treated with with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included hysterectomy on (b)(6) 2019 and salpingo-oophorectomy on (b)(6) 2019.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 adenomyosis.Notes: outpatient patient background: concurrent condition before surgery: none.Diabetes mellitus: none.Surgical history: none.Historical conditions: none.Allergic predisposition: none.Underlying disease before surgery (surgical indication): adenomyosis uteri patient's condition: preoperative condition: generally healthy, good nutrition status, no anaemia, no radiotherapy.Concomitant medications included cefmetazole sodium (cefmetazole sodium) for infection prophylaxis.On (b)(6) 2019, the patient was hospitalized.On (b)(6) 2019, the patient underwent a surgery (which was an elective surgery).Operative procedure/reconstruction method: abdominal simple total hysterectomy and adnexectomy bilateral (intraoperative hyperthermic therapy: none) were performed, and seprafilm (amount used, unknown) was used.Application sites: retroperitoneal opening, parietal peritoneum incision site (infection in the application site: none) direct application to the anastomosis site: no condition of application: favorable operating surgeon's experience in using seprafilm: experienced (multiple cases) surgical situation: drain placement site: none pre-existing adhesion: none intraperitoneal: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: yes (2 l) anastomosis of resection site resection site: yes (site: vagina) pre-existing non-purulent inflammation: none, pre-existing infection: none anastomosis method for the resection site: hand suture, interrupted anastomosis suture: inner and outer layers: the first layer, vicryl (absorbable, synthetic, multi thread) ligature: absorbable, synthetic, multi thread (vicryl) status of operative field: clean-contaminated laparotomy wound suture laparotomy wound site: length of laparotomy incision: 25 cm anastomosis method for the skin: hand suture, interrupted anastomosis, using an absorbable, synthetic, mono thread (pdsii) pre-existing non-purulent inflammation: none, pre-existing infection: none operative time: approximately 2 hours, amount of bleeding: 145 g, blood transfusion: none after surgery: other concomitantly used medical device: none on (b)(6) 2019, the patient was discharged from the hospital.On (b)(6) 2019, the patient had abdominal pain and pyrexia of 38.5°c at home.Abscess (application site) developed in the sites corresponding with both sites (retroperitoneal opening, parietal peritoneum incision site).(method of confirmation of the adverse event: ct) it was considered that positional relationship between the site of abscess and the seprafilm application site was apparently identical.On (b)(6) 2019, the patient visited the emergency outpatient department (of the reporting hospital).The patient was diagnosed with intra-abdominal infection and was hospitalized again and started to receive antibiotics.Wbc was 16800/ul, crp was 20.61 mg/dl, and neu was 89.6% histological examination, if the event was considered to be foreign body reaction: the result was pending, and detailed examination was ongoing.Prolongation of hospitalization: no on (b)(6) 2019, transvaginal drainage was performed the vaginal stump abscess.On (b)(6) 2019, as the abscess directly under the abdominal wall did not improve, laparotomy drainage was performed.The patient was treated with antibiotics after the surgery.Bacterial culture was performed.Specimen: pus (site: intraperitoneal area) types of bacteria to be tested: general aerobes, general anaerobes, enterococcus, mrsa, pseudomonas aeruginosa, escherichia coli bacteria detected: escherichia coli re-laparotomy: yes situation of the re-laparotomy: there were adhesion findings only in the in the application sites.Abscess in the adhesion sites.Condition of seprafilm: completely absorbed into the body.Removal of seprafilm: unable to be removed other measures taken: yes (adhesiolysis, irrigation) adverse event after the re-laparotomy: recovering on (b)(6) 2019 the patient was recovering and discharged from the hospital.On (b)(6) 2019, pyrexia of 38.5°c, abscess (application site), and abdominal pain resolved.The patient developed an event of a serious abscess (application site).This event was leading to intervention.The patient was hospitalized 1 day after this event occurred.The patient was discharged on (b)(6) 2019 (hospitalization during 17 days).The patient developed an event of a serious abdominal pain.This event was leading to intervention.The patient was hospitalized 1 day after this event occurred.The patient was discharged on (b)(6) 2019 (hospitalization during 17 days).The patient developed an event of a serious pyrexia of 38.5°c.This event was leading to intervention.The patient was hospitalized 1 day after this event occurred.The patient was discharged on (b)(6) 2019 (hospitalization during 17 days).Relevant laboratory test results included: bacterial test - on (b)(6) 2019 [bacteria detected: escherichia coli] body temperature - on(b)(6) 2019: 38.5 cel c-reactive protein - on (b)(6) 2019: 20.61 mg/dl neutrophil count - on (b)(6) 201989.6 % white blood cell count - on (b)(6) 2019: 16800 /ul.Final diagnosis was severe abscess (application site).The patient was treated with piperacillin sodium,tazobactam sodium (tazopipe) for abdominal infection, meropenem trihydrate (meropenem [meropenem trihydrate]) for abdominal infection and ampicillin sodium,sulbactam sodium (sulbacillin) for abdominal infection.The patient outcome is reported as recovered / resolved on (b)(6) 2019 for abscess (application site), as recovered / resolved on (b)(6) 2019 for abdominal pain and as recovered / resolved on (b)(6) 2019 for pyrexia of 38.5°c.Reporter comment: the causal relationship between seprafilm and abscess: unknown.Reporter comment on (b)(6) 2019: abscess (application site): causality between the event and seprafilm: probable other factor(s) suspected to have caused the adverse event: unknown comments on the causal relationship between the adverse event and seprafilm: there were no adhesion findings besides those in the application sites (vaginal stump, directly under the abdominal wall).No finding of intestinal leakage was noted during the re-laparotomy.At least, it was the problem of the application sites, and the reporter considered that the risk of the use of seprafilm in clean-contaminated surgeries such as hysterectomy should be considered similar to that of intestinal anastomosis.Additional information was received on 11-sep-2019 from the physician: updated seriousness of the event; and updated clinical course.Additional information was received on 23-sep-2019: investigation summary (investigation summary #220771, event id 60167) was reported (added it in company comment field).Additional information was received on 24-oct-2019 by the physician: added patient information, added other relevant history, added lab data, added concomitant drugs and treatment drugs, updated indication of seprafilm, changed the event term (as reported), updated the onset date, recovery date, outcome, intensity, treatment, and hospitalization details, added symptoms "abdominal pain, pyrexia of 38.5°c", and updated reporter comment and clinical course.
|
