| Lot Number 7BYSEP031 |
| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problem
Abscess (1690)
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| Event Date 11/30/2019 |
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Event Type
Injury
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Event Description
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Abscess (application site) [medical device site abscess].Case narrative: initial information received on 11-dec-2019 regarding an unsolicited valid serious case received from (lp) (b)(6) under reference on (b)(6) 2019 and transmitted to sanofi.This case involves adult female patient who experienced abscess (application site), 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.Use of sepra wrap: none.Concurrent use of other medical device: none.On (b)(6) 2019, seprafilm (sample for clinical use) was used.The physician who participated in the operation was usually using interceed.During total hysterectomy, 2 sheets of seprafilm were used at the sutures in the retroperitoneum (application site: sutures in the retroperitoneum).The operation was completed without any particular problem.The attending physician had only limited experience in using seprafilm.On an unknown date, abscess developed at the application site.(the causality between onset sited and application site was certain.) on an unknown date, the abscess (application site) was resolving.The patient developed an event of a serious abscess (application site).This event was leading to intervention.The patient was hospitalized for this event.Final diagnosis was severe abscess (application site).It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovering / resolving for abscess (application site).Reporter comment: causality between seprafilm and abscess (application site): probable.Possible causative factors for abscess (application site) other than seprafilm: unknown.Physician's or pharmacist's comment: the physician had experienced nearly 1000 cases of operations so far, but such abscess had never occurred before.The use of seprafilm was a different approach than usual, and thus the event was considered to be probably related to seprafilm.
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Event Description
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Intrapelvic abscess (application site) [medical device site abscess] sepsis [sepsis].Pelvic peritonitis [pelvic peritonitis] ([pyrexia], [abdominal pain lower], [diarrhoea]).Case narrative: initial information received on (b)(6) 2019 regarding an unsolicited valid serious case received from (lp) (b)(4) under reference (b)(4) on (b)(6) 2020 and transmitted to sanofi.This case involves a 42 years old female patient (151 cm and 55.35 kg) who experienced intrapelvic abscess (application site), sepsis and pelvic peritonitis, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included drug hypersensitivity.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 and endometriosis, and was non-tobacco user.Notes: in patient.Use of sepra wrap: none.Concurrent use of other medical device: none.[patient background] concurrent condition before surgery: none.Diabetes mellitus: none.History of surgery: none.Historical condition: none.Allergic factor: present (banan tablets).[before surgery].Underlying disease: adenomyosis uteri, bilateral ovarian chocolate cyst patient's condition: condition before surgery: generally healthy, nutritional condition: favorable, anemia: none, radiation therapy: none.[date of surgery and operative method] hospitalization date: (b)(6) 2019, discharge date: (b)(6) 2019.Date of surgery: (b)(6) 2019 (scheduled).Operative method/reconstructive surgery: total laparoscopic.Hysterectomy+enucleation of bilateral ovarian chocolate cyst (tlh+lc) intraoperative hyperthermia: none.[application of seprafilm] application site: vaginal stump (infection at the application site: none).Direct application to anastomotic site: no, number of sheets: 1.Application status: defect (cracked), experience of using seprafilm by the surgeon: present (the patient is the 5th patient).Surgery status: site of drain placement: present (drain type: penrose drain 6 mm) pre-existing adhesion: present (site: bilateral ovaries, douglas' pouch), detachment: present.Intra-abdominal status: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: present (1 l).[anastomosis of excision site] excision site: present (vaginal stump) pre-existing non-purulent inflammation: none pre-existing infection: none.Method for anastomosis of excision site: hand-stitch (continuous) suture thread (type): inner layer (name: 0 vicryl) absorbable, synthetic, multiple status of operative field: clean-contaminated surgery [suture of open abdominal wound] length of open abdominal wound: 2-0.5 cm, suture layer: 1 layer suture method for the 1st layer (peritonea): node, suture threat: absorbable, synthetic, multiple (name: 0 vicryl) suture method for skin: hand suture (node), suture threat: absorbable, synthetic, multiple (name: 4-0 vicryl rapide) pre-existing non-purulent inflammation: none, pre-existing infection: none surgery duration: about 2 hours, loss of blood volume: 50 ml, blood transfusion: none [after surgery] other concomitantly-used medical device: present (open drain, placed on (b)(6), removed on (b)(6)) status of drained fluid: soon after placement: favorable.Obstetrics and gynecology: no.[examination/treatment for the events] fungal culture: not performed infection/inflammation-related laboratory test: wbc: 11200, crp: 32.0 (test date: on (b)(6) 2019) histological examination if diagnosis of foreign-body reaction was made: none prolongation of hospitalization: no re-hospitalization for treatment: re-hospitalized (date of re-hospitalization: (b)(6) 2019, discharge date: on (b)(6) 2019).Re-laparotomy: no.Concomitant medications included fosfomycin sodium (fosfomycin sodium) for infection prophylaxis.On (b)(6) 2019, the patient visited a clinic with chief complaints of menses painful, prolonged menstruation, and menorrhagia, and was diagnosed as having adenomyosis uteri and left ovarian chocolate cyst.The patient started taking dienogest but noticed irregular vaginal bleeding and chronic pelvic pain and was recommended to undergo surgery.On (b)(6) 2019, the patient visited the reporter's department with a referral, where a diagnosis of adenomyosis uteri and bilateral ovarian chocolate cyst was made and surgery was decided.On (b)(6) 2019, the patient was hospitalized for surgery.On (b)(6) 2019, the operating surgeon had usually been using interceed and had tried a clinical sample of seprafilm in this case.The operating surgeon was present at the scene of surgery using seprafilm.Total laparoscopic hysterectomy and removal of the bilateral ovarian chocolate cyst were performed.Two sheets of seprafilm were applied to the suture site of the retroperitoneum (application site: the suture site of the retroperitoneum, lot number: 7bysep031) at 11:14, the surgery was started.Course of the surgery: 1.After longitudinal incision of the bottom of the umbilicus, a 12 mm trocar catheter was inserted with direct method.A scope was inserted, and after confirming that the trocar catheter was inserted in the abdominal cavity, pneumoperitoneum was started.After transverse incision of the left and right flank regions/the umbilicus and the central part of the pubic bone, a 5 mm trocar catheter was inserted.2.The abdominal cavity was observed.The uterus was swollen to the size of a goose egg and the mobility was good.The left and right ovaries were swollen to the size of a pigeon egg.They were adherent to the posterior lobe of broad ligament, and kissing ovary was diagnosed.A small amount of light-yellow ascites was observed, and the washing ascites was collected for cytology.There were no abnormalities in the upper abdominal region, including liver, bladder, and stomach.3.The left and right ovaries were taken off the posterior lobe of broad ligament.During the operation, the part of the cyst was ruptured, and the chocolate-like content fluid leaked.The right adnexectomy was completely isolated and local injection of 200-fold diluted pitressin was administered to the capsule of the right ovarian chocolate cyst.The cyst was removed and submitted for a rapid diagnostic test.Coagulation/ hemostasis of the bleeding site of the exhumed surface was performed using biclamp.4.The left ovarian chocolate cyst was removed and submitted for a rapid diagnostic test similarly.5.After incision of the excavatio vesicouterina peritoneum, the bladder was displaced and detached inferiorly.6.After incision and expansion of the left and right posterior lobe of broad ligament, the uterine artery was fixed while aspirating and removing the connective tissues around the umbilical lateral ligament.After ligation of the uterine artery using 2-0 vicryl thread, uterine side was cut with harmonic ace.7.The left and right round ligaments, fallopian tubes, and ovarian ligaments were coagulated with biclamp and cut with harmonic ace.8.After the left and right ureters were detached from the posterior lobe of broad ligament and the course of the ureters was confirmed, the posterior lobe of broad ligament was cut and expanded to the position of the uterosacral ligament.9.The left and right cardinal ligaments were coagulated with biclamp paying attention to the course of the ureters and cut with harmonic ace.10.After insertion of a vagipipe, incision of the vaginal portion of cervix was performed with monopolar.After the posterior fornix and anterior fornix of the vagina were opened, the left and right paracolpium were coagulated with biclamp and cut, and the uterus was removed.The uterus was transvaginally collected.It weighted 120 g.11.After single-knot suture of the left and right sides of the vaginal stump using 0 vicryl thread, continuous suture between them was performed.12.Intraperitoneal irrigation with 100 ml of warm saline was performed and absence of bleeding was confirmed.13.Continuous suture of vaginal stump only to the peritoneum was performed using 2-0 vicryl thread.14.After intravenous injection of indigocarmine at 1 a, saline at 100 ml was infused into the bladder and the balloon catheter was removed.A scope was inserted from the urethral opening into the bladder for observation of the inside of the bladder, and urine outflow from the left and right ureters was confirmed.15.No outflow of indigocarmine into the abdominal cavity was observed, and absence of bladder injury and bleeding were confirmed.Seprafilm was applied to the defect in the peritoneum, a 6 mm penrose drain was placed in the douglas' pouch, and all of the trocar catheters were removed.After z suture of the umbilicus using 0 vicryl thread, continuous suture using 4-0 vicryl rapide thread was performed.16.Absence of abnormal bleeding was confirmed by examination using a cusco, and the surgery was completed.The surgery was completed without particular troubles during surgery.At 13:30, the surgery was completed.Time of surgery: 2 hours and 16 minutes, amount of bleeding: 50 ml, anesthesia: general anesthesia the patient had a good postoperative course without problems.On (b)(6) 2019, the patient was discharged from the hospital in a good condition.On (b)(6) 2019, after discharge, pyrexia, lower abdominal pain, and diarrhoea persisted.The patient visited the reporting physician's department and was urgently hospitalized for a diagnosis of abscess in the pelvis (positional relationship between the development site and the application site: the site was considered to be the application site obviously) and pelvic peritonitis.The wbc and crp were 11200 and 32.0, respectively.Sepsis developed.Meropenem at 0.5 g twice a day was administered for 5 days.The pyrexia rapidly declined, and the lower abdominal pain improved as well.The pyrexia and lower abdominal pain were resolving.Method of confirmation of the adverse events: ct, others: ultrasonography on (b)(6) 2019, the patient was discharged from the hospital in a good condition.The wbc and crp were 6100 and 2.7, respectively.On (b)(6) 2019, postoperative examinations were performed.The sepsis, pelvic peritonitis, and diarrhoea were resolving.On an unknown date, the abscess in the pelvis (at the application site) was resolving.The patient developed an event of a serious intrapelvic abscess (application site) (medical device site abscess).This event was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient was discharged on (b)(6) 2019 (hospitalization during 6 days).The patient developed an event of a serious sepsis.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 6 days).The patient developed an event of a serious pelvic peritonitis (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 6 days).The patient developed an event of a serious pyrexia.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 6 days).The patient developed an event of a serious abdominal pain lower.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 6 days).The patient developed an event of a serious diarrhoea.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 6 days).Relevant laboratory test results included: c-reactive protein ( - 0.3 mg/dl) - on (b)(6) 2019: 32.0 mg/dl (borderline) [h]; on (b)(6) 2019: 2.7 mg/dl (borderline) white blood cell count (35 - 93 10*2) - on (b)(6) 2019: 112 10*2 (borderline) [h]; on (b)(6) 2019: 61 10*2 final diagnosis was moderate pelvic peritonitis, moderate sepsis and severe intrapelvic abscess (application site).The patient was treated with meropenem (meropenem) for infection.The patient outcome is reported as recovering / resolving for intrapelvic abscess (application site), as recovering / resolving for pelvic peritonitis, as recovering / resolving for sepsis, as recovering / resolving for pyrexia, as recovering / resolving for abdominal pain lower and as recovering / resolving for diarrhoea.Reporter comment: [intrapelvic abscess (application site)] causality between seprafilm and the event: probable possible causative factors for the event other than seprafilm: unknown physician's comment: the physician had experienced nearly 1000 cases of operations so far, but such abscess had never occurred before.The use of seprafilm was a different approach than usual, and thus the event was considered to be probably related to seprafilm.[pelvic peritonitis and associated symptoms, sepsis].Causality between seprafilm and the events: probable.Possible causative factors for the events other than seprafilm: unknown.Statement on the events: probably seprafilm-related infection/inflammation.Additional information was received on (b)(6) 2019: no new information was received.Additional information was received on (b)(6) 2020 from the physician: added events "pelvic peritonitis (symptoms: pyrexia, abdominal pain lower, and diarrhoea)" and "sepsis"; changed the event term from "abscess (application site)" to "intrapelvic abscess (application site)"; updated reporter information; updated the patient's initials, age, birth date, height, weight; updated other relevant history, laboratory data, information on the suspect drug (lot number and indication for use), and administration information on the concomitant drug and the treatment drug; and updated clinical course and reporter comment.
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Event Description
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Intrapelvic abscess (application site) [medical device site abscess], sepsis [sepsis] , pelvic peritonitis [pelvic peritonitis] ([pyrexia], [abdominal pain lower], [diarrhoea]).Case narrative: initial information received on 11-dec-2019 regarding an unsolicited valid serious case received from a physician.This case involves a 42 years old female patient (151 cm and 55.35 kg) who experienced intrapelvic abscess (application site), sepsis and pelvic peritonitis, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history were not provided.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 and endometriosis, was non-tobacco user and drug hypersensitivity.Notes: inpatient.Use of sepra wrap: none.Concurrent use of other medical device: none.[patient background]: concurrent condition before surgery: none.Diabetes mellitus: none.History of surgery: none.Historical condition: none.Allergic factor: present (banan tablets).[before surgery]: underlying disease: adenomyosis uteri, bilateral ovarian chocolate cyst.Patient's condition: condition before surgery: generally healthy, nutritional condition: favorable, anemia: none, radiation therapy: none.[date of surgery and operative method]: hospitalization date: (b)(6) 2019, discharge date: (b)(6) 2019 date of surgery: (b)(6) 2019 (scheduled).Operative method/reconstructive surgery: total laparoscopic.Hysterectomy+enucleation of bilateral ovarian chocolate cyst (tlh+lc).Intraoperative hyperthermia: none.[application of seprafilm]: application site: vaginal stump (infection at the application site: none).Direct application to anastomotic site: no, number of sheets: 1.Application status: defect (cracked), experience of using seprafilm by the surgeon: present (the patient is the 5th patient).Surgery status: site of drain placement: present (drain type: penrose drain 6 mm) pre-existing adhesion: present (site: bilateral ovaries, douglas' pouch), detachment: present.Intra-abdominal status: pre-existing non-purulent inflammation: none, pre-existing.Infection: none, intraperitoneal irrigation: present (1 l).[anastomosis of excision site].Excision site: present (vaginal stump).Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Method for anastomosis of excision site: hand-stitch (continuous).Suture thread (type): inner layer (name: 0 vicryl) absorbable, synthetic, multiple.Status of operative field: clean-contaminated surgery.[suture of open abdominal wound]: length of open abdominal wound: 2-0.5 cm, suture layer: 1 layer.Suture method for the 1st layer (peritonea): node, suture threat: absorbable, synthetic, multiple (name: 0 vicryl).Suture method for skin: hand suture (node), suture threat: absorbable, synthetic, multiple (name: 4-0 vicryl rapide.Pre-existing non-purulent inflammation: none, pre-existing infection: none.Surgery duration: about 2 hours, loss of blood volume: 50 ml, blood transfusion: none.[after surgery]: other concomitantly-used medical device: present (open drain, placed on (b)(6) , removed on (b)(6) ).Status of drained fluid: soon after placement: favorable.Obstetrics and gynecology: no.[examination/treatment for the events]: fungal culture: not performed.Infection/inflammation-related laboratory test: wbc: 11200, crp: 32.0 (test date: (b)(6) 2019).Histological examination if diagnosis of foreign-body reaction was made: none.Prolongation of hospitalization: no.Re-hospitalization for treatment: re-hospitalized (date of re-hospitalization: (b)(6) 2019, discharge date: (b)(6) 2019).Re-laparotomy: no.Concomitant medications included fosfomycin sodium (fosfomycin sodium) for infection prophylaxis.On (b)(6) 2019, the patient visited a clinic with chief complaints of menses painful, prolonged menstruation, and menorrhagia, and was diagnosed as having adenomyosis uteri and left ovarian chocolate cyst.The patient started taking dienogest but noticed irregular vaginal bleeding and chronic pelvic pain and was recommended to undergo surgery.On (b)(6) 2019, the patient visited the reporter's department with a referral, where a diagnosis of adenomyosis uteri and bilateral ovarian chocolate cyst was made and surgery was decided.On (b)(6) 2019, the patient was hospitalized for surgery.On (b)(6) 2019, the operating surgeon had usually been using interceed and had tried a clinical sample of seprafilm in this case.The operating surgeon was present at the scene of surgery using seprafilm.Total laparoscopic hysterectomy and removal of the bilateral ovarian chocolate cyst were performed.Two sheets of seprafilm were applied to the suture site of the retroperitoneum (application site: the suture site of the retroperitoneum, lot number: 7bysep031) at 11:14, the surgery was started.Course of the surgery: 1.After longitudinal incision of the bottom of the umbilicus, a 12 mm trocar catheter was inserted with direct method.A scope was inserted, and after confirming that the trocar catheter was inserted in the abdominal cavity, pneumoperitoneum was started.After transverse incision of the left and right flank regions/the umbilicus and the central part of the pubic bone, a 5 mm trocar catheter was inserted.2.The abdominal cavity was observed.The uterus was swollen to the size of a goose egg and the mobility was good.The left and right ovaries were swollen to the size of a pigeon egg.They were adherent to the posterior lobe of broad ligament, and kissing ovary was diagnosed.A small amount of light-yellow ascites was observed, and the washing ascites was collected for cytology.There were no abnormalities in the upper abdominal region, including liver, bladder, and stomach.3.The left and right ovaries were taken off the posterior lobe of broad ligament.During the operation, the part of the cyst was ruptured, and the chocolate-like content fluid leaked.The right adnexectomy was completely isolated and local injection of 200-fold diluted pitressin was administered to the capsule of the right ovarian chocolate cyst.The cyst was removed and submitted for a rapid diagnostic test.Coagulation/ hemostasis of the bleeding site of the exhumed surface was performed using biclamp.4.The left ovarian chocolate cyst was removed and submitted for a rapid diagnostic test similarly.5.After incision of the excavatio vesicouterina peritoneum, the bladder was displaced and detached inferiorly.6.After incision and expansion of the left and right posterior lobe of broad ligament, the uterine artery was fixed while aspirating and removing the connective tissues around the umbilical lateral ligament.After ligation of the uterine artery using 2-0 vicryl thread, uterine side was cut with harmonic ace.7.The left and right round ligaments, fallopian tubes, and ovarian ligaments were coagulated with biclamp and cut with harmonic ace.8.After the left and right ureters were detached from the posterior lobe of broad ligament and the course of the ureters was confirmed, the posterior lobe of broad ligament was cut and expanded to the position of the uterosacral ligament.9.The left and right cardinal ligaments were coagulated with biclamp paying attention to the course of the ureters and cut with harmonic ace.10.After insertion of a vagipipe, incision of the vaginal portion of cervix was performed with monopolar.After the posterior fornix and anterior fornix of the vagina were opened, the left and right paracolpium were coagulated with biclamp and cut, and the uterus was removed.The uterus was transvaginally collected.It weighted 120 g.11.After single-knot suture of the left and right sides of the vaginal stump using 0 vicryl thread, continuous suture between them was performed.12.Intraperitoneal irrigation with 100 ml of warm saline was performed and absence of bleeding was confirmed.13.Continuous suture of vaginal stump only to the peritoneum was performed using 2-0 vicryl thread.14.After intravenous injection of indigocarmine at 1 a, saline at 100 ml was infused into the bladder and the balloon catheter was removed.A scope was inserted from the urethral opening into the bladder for observation of the inside of the bladder, and urine outflow from the left and right ureters was confirmed.15.No outflow of indigocarmine into the abdominal cavity was observed, and absence of bladder injury and bleeding were confirmed.Seprafilm was applied to the defect in the peritoneum, a 6 mm penrose drain was placed in the douglas' pouch, and all of the trocar catheters were removed.After z suture of the umbilicus using 0 vicryl thread, continuous suture using 4-0 vicryl rapide thread was performed.16.Absence of abnormal bleeding was confirmed by examination using a cusco, and the surgery was completed.The surgery was completed without particular troubles during surgery.At 13:30, the surgery was completed.Time of surgery: 2 hours and 16 minutes, amount of bleeding: 50 ml, anesthesia: general anesthesia the patient had a good postoperative course without problems.On (b)(6) 2019, the patient was discharged from the hospital in a good condition.On (b)(6) 2019, after discharge, pyrexia, lower abdominal pain, and diarrhoea persisted.The patient visited the reporting physician's department and was urgently hospitalized for a diagnosis of abscess in the pelvis (positional relationship between the development site and the application site: the site was considered to be the application site obviously) and pelvic peritonitis.The wbc and crp were 11200 and 32.0, respectively.Sepsis developed.Meropenem at 0.5 g twice a day was administered for 5 days.The pyrexia rapidly declined, and the lower abdominal pain improved as well.The pyrexia and lower abdominal pain were resolving.Method of confirmation of the adverse events: ct, others: ultrasonography on (b)(6) 2019, the patient was discharged from the hospital in a good condition.The wbc and crp were 6100 and 2.7, respectively.On (b)(6) 2019, postoperative examinations were performed.The sepsis, pelvic peritonitis, and diarrhoea were resolving.On an unknown date, the abscess in the pelvis (at the application site) was resolving.The patient developed an event of a serious intrapelvic abscess (application site) (medical device site abscess).This event was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient was discharged on (b)(6) 2019 (hospitalization during 6 days).The patient developed an event of a serious sepsis.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 6 days).The patient developed an event of a serious pelvic peritonitis (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)(4)2019 (hospitalization during 6 days).The patient developed an event of a serious pyrexia.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 6 days).The patient developed an event of a serious abdominal pain lower.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 6 days).The patient developed an event of a serious diarrhoea.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 6 days).Relevant laboratory test results included: c-reactive protein ( - 0.3 mg/dl) - on (b)(6) 2019: 32.0 mg/dl (borderline) [h]; on (b)(6) 2019: 2.7 mg/dl (borderline).White blood cell count (35 - 93 10*2) - on (b)(6) 2019: 112 10*2 (borderline) [h]; on (b)(6) 2019: 61 10*2.Final diagnosis was moderate pelvic peritonitis, moderate sepsis and severe intrapelvic abscess (application site).The patient was treated with meropenem (meropenem) for infection.The patient outcome is reported as recovering / resolving for intrapelvic abscess (application site), as recovering / resolving for pelvic peritonitis, as recovering / resolving for sepsis, as recovering / resolving for pyrexia, as recovering / resolving for abdominal pain lower and as recovering / resolving for diarrhoea.Reporter comment: [intrapelvic abscess (application site)].Causality between seprafilm and the event: probable.Possible causative factors for the event other than seprafilm: unknown.Physician's comment: the physician had experienced nearly 1000 cases of operations so far, but such abscess had never occurred before.The use of seprafilm was a different approach than usual, and thus the event was considered to be probably related to seprafilm.[pelvic peritonitis and associated symptoms, sepsis].Causality between seprafilm and the events: probable.Possible causative factors for the events other than seprafilm: unknown.Statement on the events: probably seprafilm-related infection/inflammation.Additional information was received on 17-dec-2019: no new information was received.Additional information was received on 14-jan-2020 from the physician: added events "pelvic peritonitis (symptoms: pyrexia, abdominal pain lower, and diarrhoea)" and "sepsis"; changed the event term from "abscess (application site)" to "intrapelvic abscess (application site)"; updated reporter information; updated the patient's initials, age, birth date, height, weight; updated other relevant history, laboratory data, information on the suspect drug (lot number and indication for use), and administration information on the concomitant drug and the treatment drug; and updated clinical course and reporter comment.Additional information was received on 23-jan-2020: no new information was received.Additional information was received on 12-feb-2020: received investigation summary (investigation summary #(b)(4), event id: (b)(4)), added reporter information.Updated company comment.
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