| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Erythema (1840); Hemorrhage/Bleeding (1888); Inflammation (1932); Peritonitis (2252); Post Operative Wound Infection (2446)
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| Event Date 10/29/2018 |
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Event Type
Injury
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Event Description
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Peritonitis [peritonitis].Wound infection [postoperative wound infection] ([redness], [induration], [tenderness], [feeling hot]), abscess [abscess].Case narrative: initial information received on 24-may-2019 regarding an unsolicited valid serious case received from (b)(6) under reference on 24-may-2019 and transmitted to sanofi.This case involves a (b)(6) years old female patient ((b)(6)) who experienced peritonitis, wound infection and abscess, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis, wound infection, redness around the wound, induration around the wound, tenderness around the wound, feeling hot around the wound and abscess 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 was not reported.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 obstructed labour and was a non-tobacco user.Notes: inpatient/outpatient: inpatient.Patient background.Preoperative complications: none.Diabetes mellitus: none.History of surgery: none.Past medical history: none.Allergy disposition: none.Smoking: none.Before surgery.Underlying disease: obstructed labour due to cephalo-pelvic disproportion.Patient condition: preoperative condition: general health and nutrition condition: good, anaemia: none, radiotherapy: none.Date of surgery and operative method.Day of admission: (b)(6) 2018, day of discharge: (b)(6) 2018.Day of surgery: (b)(6) 2018 (not elective surgery).Operative/reconstruction method: caesarean section.Application of seprafilm.Application site: anterior wall of the uterus (infection at the application site: none) direct application to the anastomotic site: presence, number of the sheet: (qp) 4 sheets application condition: good, the operator's use experience of seprafilm: presence (this patient was the 10th case).Condition of the surgery: site of placement of drain: none.Pre-existing adhesion: none.In the abdominal cavity: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: none.Anastomosis of the excision site: presence or absence of the excision site: absence.Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Suture thread (kind): inner layer (name: polysorb) absorbent, synthetic, and multi ligature (kind): absorbent, synthetic, and multi condition of surgical field: sterility (cleanliness) surgery (clean).Suture of laparotomy wound.Length of the laparotomy wound: 10 cm.Suture method of the first layer (peritoneum): continuous suture, suture thread: absorbent, synthetic, and multi (name: polysorb).Method of suture of the skin: hand-stitch (continuous), suture thread: absorbent, synthetic, and mono.Pre-existing non-purulent inflammation: none, pre-existing infection: none, time of the surgery: about 40 minutes, amount of bleeding and amnion fluid: 620 g, blood transfusion: none.After surgery: other concomitantly used medical devices: none.In case of the department of obstetrics and gynecology: none.Concomitant medications included amoxicillin hydrate (amoxicillin hydrate) for product used for unknown indication; prostaglandin e2 (prostaglandin e2) for product used for unknown indication; flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis; diclofenac potassium (voltaren acti) for product used for unknown indication; alisma plantago-aquatica var.Orientale tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp.Root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var.Inermis fruit (saireito [alisma plantagoaquatica var.Orientale tuber; atractylodes lancea rhizome;bupleurum falcatum root;cinnamomum cassia bark;glycyrrhiza spp.Root; panax ginseng root;pinellia ternata tuber;polyporus umbellatus sclerotium;poria cocos sclerotium;) for product used for unknown indication; loxoprofen sodium (loxoprofen na) for product used for unknown indication; and cefdinir (cefdinir) for product used for unknown indication.On (b)(6) 2018, (b)(6) of pregnancy, the patient was admitted to the reporter's hospital for induction of delivery.The patient took abpc, an antibacterial drug, prophylactically (vaginal secretion biopsy at (b)(6) of pregnancy was negative for gbs).On (b)(6) 2018, the patient began to have a labor pain spontaneously, which, however, did not progress.A diagnosis of obstructed labour due to cephalo-pelvic disproportion was made, and caesarean section was performed.Membrane rupture had not yet occurred, and the mother had no pyrexia.Infection ascending from the vagina was not suspected.At the caesarean section, no pus in the intrauterine cavity or findings of infection, such as foul smell, were observed.Before opening the abdominal cavity, seprafilm was applied to the uterine wound and the anterior wall of uterus.After surgery, the vital signs, body temperature, and bleeding were coincided with the usual course after caesarean section.On the day of surgery and on the day after surgery, flumarin injection, an antibacterial drug, at 2 g/day was administered.On (b)(6) 2018, on postoperative day (pod) 1, no abnormalities were observed.On (b)(6) 2018, on pod 3, transvaginal ultrasonography and cusco speculum examination showed no abnormalities.The tendency toward dehiscence of the epidermis was observed at the bottom edge of the caudal site of the wound, and it was again fixed with tape.On (b)(6) 2018, on pod 5, redness, induration, tenderness, and feeling hot around the wound were observed.The body temperature was 36.8 degrees centigrade.A blood test showed wbc 11810 and crp 10.Wound infection was suspected, and the antibacterial drug was switched to finibax.Bacterial culture: sample name: lochia, bacterial species for the examination target: aerobes and anaerobes, isolated bacteria: none.Wound infection, peritonitis, and abscess developed (severity: moderate).Peritonitis, abscess: the appearance site was obviously considered as the application site.On (b)(6) 2018, on pod 7, the findings remained unchanged.The abdominal pain slightly increased.A blood test showed no deterioration nor tendency toward improvement with wbc 10300 and crp 12.3.Ultrasound scan vagina: echo free space on the anterior surface of the uterus suggesting abscess formation on the same date, the patient was transferred to the department of obstetrics and gynecology of medical center b.On an unknown date, at the medical center, re-laparotomy showed abscess formation around the uterine wound, and the part of the myometrium was resected and again sutured.Then, drainage was performed.The 4th bacterial culture yielded fungi, but contamination of the surgical field could not be denied.On an unknown date, the wound infection, tenderness around the wound, feeling hot around the wound, redness around the wound, induration around the wound, peritonitis, and abscess resolved.The patient developed an event of a serious peritonitis.This event was assessed as medically significant.Due to this event, patient's hospitalization was prolonged.The patient developed an event of a serious wound infection.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious abscess.Due to this event, patient's hospitalization was prolonged.The patient developed an event of a serious redness around the wound.This event was assessed as medically significant.Due to this event, patient's hospitalization was prolonged.The patient developed an event of a serious induration around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious tenderness around the wound.This event was assessed as medically significant.Due to this event, patient's hospitalization was prolonged.The patient developed an event of a serious feeling hot around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.Relevant laboratory test results included: bacterial test - on (b)(6) 2018: [sample name: lochia, bacterial species for the examination target: aerobes and anaerobes, isolated bacteria: none]; on an unknown date: [the 4th bacterial culture yielded fungi, but contamination of the surgical field could not be denied] body temperature - on (b)(6) 2018: 36.8 cel.C-reactive protein - on (b)(6) 2018: 10 [10]; on (b)(6) 2018: 12.3 [12.3].Culture - on an unknown date: negative [gbs negative].Ultrasound scan vagina - on (b)(6) 2018: [echo free space on the anterior surface of the uterus suggesting abscess formation].White blood cell count - on (b)(6) 2018: 11810 [11810]; on (b)(6) 2018: 10300 [10300].Final diagnosis was moderate abscess, moderate wound infection and moderate peritonitis.The patient was treated with doripenem (finibax).The patient outcome is reported as recovered / resolved on an unknown date for abscess, as recovered / resolved on an unknown date for peritonitis, as recovered / resolved on an unknown date for wound infection, as recovered / resolved on an unknown date for redness around the wound, as recovered / resolved on an unknown date for induration around the wound, as recovered / resolved on an unknown date for tenderness around the wound and as recovered / resolved on an unknown date for feeling hot around the wound.Additionally, at time of reporting, the outcome of the pregnancy is unknown.Outcome of the pregnancy was reported as -birth type unknown and fetal outcome was reported as outcome unknown.Reporter comment: wound infection, peritonitis, abscess.Causal relationships to seprafilm: probable.Other possible factors suggesting the cause of the adverse events: unknown.Inflammation due to the chemical reaction of seprafilm was strongly suspected because abscess was formed under the condition that there were no causes for infection and the responsible bacteria could not be identified.
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Event Description
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Peritonitis [peritonitis].Wound infection [postoperative wound infection] ([redness], [induration], [tenderness], [feeling hot]).Abscess [abscess].Case narrative: initial information received on 24-may-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference on (b)(6) 2019 and transmitted to sanofi.This case involves a 29 years old female patient (160 cm and 61 kg) who experienced peritonitis, wound infection and abscess, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis, wound infection, redness around the wound, induration around the wound, tenderness around the wound, feeling hot around the wound and abscess 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 was not reported.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 obstructed labour and was a non-tobacco user.Notes: inpatient/outpatient: inpatient.Patient background: preoperative complications: none.Diabetes mellitus: none.History of surgery: none.Past medical history: none.Allergy disposition: none.Smoking: none.Before surgery underlying disease: obstructed labour due to cephalo-pelvic disproportion.Patient condition: preoperative condition: general health and nutrition condition: good, anaemia: none, radiotherapy: none.Date of surgery and operative method.Day of admission:(b)(6) 2018, day of discharge: (b)(6) 2018.Day of surgery:(b)(6) 2018 (not elective surgery).Operative/reconstruction method: caesarean section.Application of seprafilm.Application site: anterior wall of the uterus (infection at the application site: none).Direct application to the anastomotic site: presence, number of the sheet: (qp) 4 sheets application condition: good, the operator's use experience of seprafilm: presence (this patient was the 10th case).Condition of the surgery: site of placement of drain: none.Pre-existing adhesion: none.In the abdominal cavity: pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: none.Anastomosis of the excision site: presence or absence of the excision site: absence.Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Suture thread (kind): inner layer (name: polysorb) absorbent, synthetic, and multi ligature (kind): absorbent, synthetic, and multi.Condition of surgical field: sterility (cleanliness) surgery (clean).< suture of laparotomy wound> length of the laparotomy wound: 10 cm.Suture method of the first layer (peritoneum): continuous suture, suture thread: absorbent, synthetic, and multi (name: polysorb).Method of suture of the skin: hand-stitch (continuous), suture thread: absorbent, synthetic, and mono.Pre-existing non-purulent inflammation: none, pre-existing infection: none, time of the surgery: about 40 minutes, amount of bleeding and amnion fluid: 620 g, blood transfusion: none.After surgery: other concomitantly used medical devices: none.In case of the department of obstetrics and gynecology: none.Concomitant medications included amoxicillin hydrate (amoxicillin hydrate) for product used for unknown indication; prostaglandin e2 (prostaglandin e2) for product used for unknown indication; flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis; diclofenac potassium (voltaren acti) for product used for unknown indication; alisma plantago-aquatica var.Orientale tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp.Root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var.Inermis fruit (saireito [alisma plantagoaquatica var.Orientale tuber;atractylodes lancea rhizome;bupleurum falcatum root;cinnamomum cassia bark;glycyrrhiza spp.Root; panax ginseng root;pinellia ternata tuber;polyporus umbellatus sclerotium;poria cocos sclerotium;) for product used for unknown indication; loxoprofen sodium (loxoprofen na) for product used for unknown indication; and cefdinir (cefdinir) for product used for unknown indication.On (b)(6) 2018, 40 weeks and 4 days of pregnancy, the patient was admitted to the reporter's hospital for induction of delivery.The patient took abpc, an antibacterial drug, prophylactically (vaginal secretion biopsy at 36 weeks of pregnancy was negative for gbs).On (b)(6) 2018, the patient began to have a labor pain spontaneously, which, however, did not progress.A diagnosis of obstructed labour due to cephalo-pelvic disproportion was made, and caesarean section was performed.Membrane rupture had not yet occurred, and the mother had no pyrexia.Infection ascending from the vagina was not suspected.At the caesarean section, no pus in the intrauterine cavity or findings of infection, such as foul smell, were observed.Before opening the abdominal cavity, seprafilm was applied to the uterine wound and the anterior wall of uterus.After surgery, the vital signs, body temperature, and bleeding were coincided with the usual course after caesarean section.On the day of surgery and on the day after surgery, flumarin injection, an antibacterial drug, at 2 g/day was administered.On (b)(6) 2018, on postoperative day (pod) 1, no abnormalities were observed.On (b)(6) 2018, on pod 3, transvaginal ultrasonography and cusco speculum examination showed no abnormalities.The tendency toward dehiscence of the epidermis was observed at the bottom edge of the caudal site of the wound, and it was again fixed with tape.On (b)(6) 2018, on pod 5, redness, induration, tenderness, and feeling hot around the wound were observed.The body temperature was 36.8 degrees centigrade.A blood test showed wbc 11810 and crp 10.Wound infection was suspected, and the antibacterial drug was switched to finibax.Bacterial culture: sample name: lochia, bacterial species for the examination target: aerobes and anaerobes, isolated bacteria: none wound infection, peritonitis, and abscess developed (severity: moderate).Peritonitis, abscess: the appearance site was obviously considered as the application site.On (b)(6) 2018, on pod 7, the findings remained unchanged.The abdominal pain slightly increased.A blood test showed no deterioration nor tendency toward improvement with wbc 10300 and crp 12.3.Ultrasound scan vagina: echo free space on the anterior surface of the uterus suggesting abscess formation on the same date, the patient was transferred to the department of obstetrics and gynecology of medical center b.On an unknown date, at the medical center, re-laparotomy showed abscess formation around the uterine wound, and the part of the myometrium was resected and again sutured.Then, drainage was performed.The 4th bacterial culture yielded fungi, but contamination of the surgical field could not be denied.On an unknown date, the wound infection, tenderness around the wound, feeling hot around the wound, redness around the wound, induration around the wound, peritonitis, and abscess resolved.The patient developed an event of a serious peritonitis.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious wound infection.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious abscess.Due to this event, patient's hospitalization was prolonged.The patient developed an event of a serious redness around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious induration around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious tenderness around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.The patient developed an event of a serious feeling hot around the wound.This event was assessed as medically significant.Due to this event patient's hospitalization was prolonged.Relevant laboratory test results included: bacterial test - on (b)(6) 2018: [sample name: lochia, bacterial species for the examination target: aerobes and anaerobes, isolated bacteria: none]; on an unknown date: [the 4th bacterial culture yielded fungi, but contamination of the surgical field could not be denied] body temperature - on (b)(6) 2018: 36.8 cel.C-reactive protein - on (b)(6) 2018: 10 [10]; on (b)(6) 2018: 12.3 [12.3].Culture - on an unknown date: negative [gbs negative].Ultrasound scan vagina - on (b)(6) 2018: [echo free space on the anterior surface of the uterus suggesting abscess formation].White blood cell count - on (b)(6) 2018: 11810 [11810]; on (b)(6) 2018: 10300 [10300].Final diagnosis was moderate abscess, moderate wound infection and moderate peritonitis.The patient was treated with doripenem (finibax).The patient outcome is reported as recovered / resolved on an unknown date for abscess, as recovered / resolved on an unknown date for peritonitis, as recovered / resolved on an unknown date for wound infection, as recovered / resolved on an unknown date for redness around the wound, as recovered / resolved on an unknown date for induration around the wound, as recovered / resolved on an unknown date for tenderness around the wound and as recovered / resolved on an unknown date for feeling hot around the wound.Additionally, at time of reporting, the outcome of the pregnancy is unknown.Outcome of the pregnancy was reported as -birth type unknown and fetal outcome was reported as outcome unknown.Reporter comment: wound infection, peritonitis, abscess.Causal relationships to seprafilm: probable.Other possible factors suggesting the cause of the adverse events: unknown.Inflammation due to the chemical reaction of seprafilm was strongly suspected because abscess was formed under the condition that there were no causes for infection and the responsible bacteria could not be identified.Additional information was received on 10-jun-2019: received investigation summary (investigation summary #(b)(4) , event id: (b)(4) ).
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Event Description
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Peritonitis [peritonitis] wound infection [postoperative wound infection] ([redness], [induration], [tenderness], [feeling hot]) abscess in uterine incision site (sterile abscess) [uterine abscess] case narrative: initial information received on 24-may-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 24-jun-2019 and transmitted to sanofi.This case involves a 29 years old female patient (160 cm and 61 kg) who experienced peritonitis, wound infection and abscess in uterine incision site (sterile abscess), while she was treated with prostaglandin e2 and with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis, wound infection, redness around the wound, induration around the wound, tenderness around the wound, feeling hot around the wound and abscess in uterine incision site (sterile abscess) 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 24-oct-2018.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 obstructed labour and was non-tobacco user.The patient had no previous pregnancy.Notes: inpatient/outpatient: inpatient.Concomitant medications included amoxicillin hydrate (amoxicillin hydrate) for infection prophylaxis; flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis; diclofenac potassium (voltaren acti) for analgesic therapy; alisma plantago-aquatica var.Orientale tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp.Root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var.Inermis fruit (saireito [alisma plantago-aquatica var.Orientale tuber;atractylodes lancea rhizome;bupleurum falcatum root;cinnamomum cassia bark;glycyrrhiza spp.Root;panax ginseng root;pinellia ternata tuber;polyporus umbellatus sclerotium;poria cocos sclerotium;) for keloid scar; loxoprofen sodium (loxoprofen na) for analgesic therapy; cefdinir (cefdinir) for infection prophylaxis; bupivacaine hydrochloride (marcain heavy) for anaesthesia procedure; ropivacaine hydrochloride (anapeine) for anaesthesia procedure; fentanyl (fentanyl) for anaesthesia procedure; metoclopramide hydrochloride (primperan) for vomiting; and oxytocin (atonin-o) for uterine contractions. preoperative complications: none diabetes mellitus: none history of surgery: none past medical history: none allergy disposition: none smoking status: non-smoker history of adverse reaction: none gravidity/parity: none underlying disease: obstructed labour due to cephalo-pelvic disproportion patient's conditions: preoperative general health and nutrition condition, good; anaemia, no; radiotherapy, no date of admission: (b)(6) 2018.Date of discharge: (b)(6) 2018.Date of surgery: (b)(6) 2018 (not prescheduled).Anesthesia: lumbar anesthesia, extradural anesthesia.Operative/reconstruction method: caesarean section. application site: anterior wall of the uterus (infection at the application site: none) direct application to the anastomotic site: yes; number of the sheet, (qp) 4 sheets application condition: good operating surgeon's experience with seprafilm: yes (this patient was the 10th case).Indwelling drain: none pre-existing adhesion: none pre-existing intraperitoneal non-purulent inflammation: none pre-existing intraperitoneal infection: none intraperitoneal irrigation: none. presence/absence of the excision site: absent pre-existing non-purulent inflammation: none pre-existing infection: none suture thread (type): inner layer (name: polysorb) absorbent, synthetic, and multi ligature (type): absorbent, synthetic, and multi condition of surgical field: aseptic (clean) surgery. length of the laparotomy wound: 10 cm suture method of the first layer (peritoneum): continuous suture, suture thread: absorbent, synthetic, and multi (name: polysorb) method of suture of the skin: hand-stitch (continuous), suture thread: absorbent, synthetic, and mono pre-existing non-purulent inflammation: none pre-existing infection: none time of the surgery: about 40 minutes amount of bleeding: 620 g including amnion fluid blood transfusion: none. use of medical device along with seprafilm: none in case of the department of obstetrics and gynecology: none. periodical measurement of mother's blood pressure: yes periodical measurement of mother's pulse: yes continuous use of delivery monitoring system: yes continuous monitoring of uterine contraction: yes continuous use of cardiotocography: yes painless labor: no.On (b)(6) 2018 , at 40 weeks and 4 days of pregnancy, the patient was admitted to the reporting hospital for induction of delivery.The patient received prophylactic antibacterial therapy with oral abpc (vaginal secretion biopsy at 36 weeks of pregnancy was negative for gbs).Due to weak labor (uterine inertia), prostaglandin e2 was administered at a dose of 0.5 mg three times.On (b)(6) 2018 prostaglandin e2 was administered at a dose of 0.5 mg six times.On (b)(6) 2018 the patient began to have a labor pain spontaneously, which, however, did not progress.A diagnosis of obstructed labour due to cephalo-pelvic disproportion was made, and caesarean section was performed.Membrane rupture did not occur.The patient had no pyrexia.There was nothing suggestive of ascending infection from the vagina.During caesarean section, there was no pus in the intrauterine cavity and there was no foul smell, suggesting that there was no infection.Before the abdominal section, seprafilm was applied to the uterine wound and the anterior wall of uterus.Post-operative vital signs, body temperature, and state of bleeding indicated that the course after caesarean section was normal.The patient received antibacterial therapy with flumarin injection at a dose of 2 g/day on the day of surgery and on the following day.On (b)(6) 2018 on postoperative day (pod) 1, no abnormalities were observed.On (b)(6) 2018 on pod 3, transvaginal ultrasonography and cusco speculum examination showed no abnormalities.The tendency toward dehiscence of the epidermis was observed at the bottom edge of the caudal site of the wound, and it was again fixed with tape.On (b)(6) 2018 on pod 5, redness, induration, tenderness, and feeling hot around the wound were observed.The body temperature was 36.8 degrees centigrade.A blood test showed wbc 11810 and crp 10.Wound infection was suspected, and the antibacterial drug was switched to finibax.Bacterial culture was performed (specimen, lochia; targets, all aerobes and anaerobes), but no bacteria was detected.The events wound infection, peritonitis, and abscess developed (severity: moderate).The site of the peritonitis and the abscess apparently coincided with the seprafilm application site.On (b)(6) 2018 on pod 7, findings remained unchanged.The abdominal pain slightly increased.A blood test showed wbc 10300 and crp 12.3, and neither deterioration nor improvement was seen.Transvaginal ultrasound showed echo free space on the anterior surface of the uterus, which was suggestive of abscess formation.On this day, the patient was transferred to the department of obstetrics and gynecology of medical center b.On an unknown date, at medical center b, a re-laparotomy was performed and revealed abscess formation around the uterine wound.After the implementation of a partial resection of the myometrium and re-suturing, drainage was performed.Reportedly, the 4th bacterial culture test detected fungi, but contamination of the surgical field could not be denied.On an unknown date, the events wound infection, tenderness around the wound, feeling hot around the wound, redness around the wound, induration around the wound, peritonitis, and abscess resolved.The patient developed a serious peritonitis 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious wound infection (postoperative wound infection) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious abscess in uterine incision site (sterile abscess) (uterine abscess) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious redness around the wound (erythema) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious induration around the wound (induration) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious tenderness around the wound (tenderness) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious feeling hot around the wound (feeling hot) 7 days following the first dose intake and 5 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.Relevant laboratory test results included: bacterial test - on (b)(6) 2018 : [specimen: lochia targets: overall aerobes and anaerobes isolated bacteria: none]; on an unknown date: [the 4th bacterial culture reportedly detected fungi, but contamination of the surgical field could not be denied also.] body temperature - on (b)(6) 2018 : 38.0 cel; on (b)(6) 2018 : 36.8 cel then 36.5 cel; on (b)(6) 2018 : 37.0 cel; on (b)(6) 2018 : 37.6 cel; on (b)(6) 2018 : 37.2 cel; on (b)(6) 2018 : 37.6 cel c-reactive protein (0 - 0 unk) - on (b)(6) 2018 : 10 unk [10]; on 31-oct-2018: 12.3 unk [12.3] culture - on an unknown date: negative [gbs negative] haematocrit (34.3 - 45 %) - on (b)(6) 2018 : 37.3 %; on (b)(6) 2018 : 31.7 %; on (b)(6) 2018 : 32.9 %; on 31-oct-2018: 29.7 % haemoglobin (11.2 - 15.2 g/dl) - on 02-oct-2018: 11.6 g/dl; on (b)(6) 2018 : 10.8 g/dl; on (b)(6) 2018 : 10.4 g/dl; on (b)(6) 2018 : 10.0 g/dl platelet count (14 - 37 10*4/ul) - on (b)(6) 2018 : 29.1 10*4/ul; on (b)(6) 2018 : 21.3 10*4/ul; on (b)(6) 2018 31.5 10*4/ul; on (b)(6) 2018 35.7 10*4/ul prothrombin time (10 - 13 second) - on 02-oct-2018: 11.8 second red blood cell count (376 - 516 10*4/ul) - on 02-oct-2018: 420 10*4/ul; on 25-oct-2018: 37.9 10*4/ul; on (b)(6) 2018 38.2 10*4/ul; on (b)(6) 2018 35.7 10*4/ul ultrasound scan vagina - on (b)(6) 2018: [echo free space on the anterior surface of the uterus was suggestive of abscess formation.] white blood cell count (3500 - 9700 /ul) - on (b)(6) 2018 : 9280 /ul; on (b)(6) 2018 : 17000 /ul; on (b)(6) 2018 : 11810 /ul; on (b)(6) 2018 : 10300 /ul.Final diagnosis was moderate abscess in uterine incision site (sterile abscess), moderate wound infection and moderate peritonitis.The patient was treated with doripenem (finibax).The patient outcome is reported as recovered / resolved on an unknown date for abscess in uterine incision site (sterile abscess), as recovered / resolved on an unknown date for peritonitis, as recovered / resolved on an unknown date for wound infection, as recovered / resolved on an unknown date for redness around the wound, as recovered / resolved on an unknown date for induration around the wound, as recovered / resolved on an unknown date for tenderness around the wound and as recovered / resolved on an unknown date for feeling hot around the wound.Additionally, at time of reporting, the patient delivered a baby at x weeks of gestation on 24-oct-18 (delivery type: cesarean).The outcome of the pregnancy was reported as live birth (nos) and fetal outcome was reported as normal/no defect.Reporter comment: [wound infection, peritonitis, abscess in uterine incision site (sterile abscess)] causal relationships to seprafilm: probable other possible causative factor: prostaglandin e2 (but this drug's contributory role was unlikely) inflammation due to chemical reaction involving seprafilm was strongly suspected, because no other infection-inducing factor was detected behind the abscess formation and also because no prophlogistic bacillus was found.[abscess in uterine incision site (sterile abscess)] the causal relationship between this event and prostaglandin e2 was unlikely.Seprafilm was a possible causative factor for the abscess in uterine incision site.This event required the patient to transfer to medical center b to undergo a re-laparotomy.Seprafilm-associated inflammation (chemical reaction) was strongly suspected to have induced this event because no other infection-inducing factor was detected behind the abscess formation and also because no prophlogistic bacillus was found.Additional information was received on 10-jun-2019: received investigation summary (investigation summary #216183, event id: 58831) additional information was received on 21-jun-2019 from the physician: changed prostaglandin e2 from concomitant drug to suspect drug, changed formulation and indication of prostaglandin e2, added pregnancy information, updated narrative, and updated reporter comment.Additional information was received on 24-jun-2019 from the physician: added lab data, added pregnancy information, updated concomitant drug information (indication, dosage), added concomitant drugs, changed the event term "abscess" to "abscess in uterine incision site (sterile abscess)", added reporter comment, and updated narrative.
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Event Description
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Peritonitis [peritonitis] wound infection [postoperative wound infection] ([redness], [induration], [tenderness], [feeling hot]) abscess in uterine incision site (sterile abscess) [uterine abscess] case narrative: initial information received on 24-may-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on (b)(6) 2019 and transmitted to sanofi.This case involves a 29 years old female patient (160 cm and 61 kg) who experienced peritonitis, wound infection and abscess in uterine incision site (sterile abscess), while she was treated with prostaglandin e2 and with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis, wound infection, redness around the wound, induration around the wound, tenderness around the wound, feeling hot around the wound and abscess in uterine incision site (sterile abscess) 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) 2018.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 obstructed labour and uterine hypotonus, and was non-tobacco user.Notes: inpatient/outpatient: inpatient concomitant medications included amoxicillin hydrate (amoxicillin hydrate) for infection prophylaxis; flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis; diclofenac potassium (voltaren acti) for analgesic therapy; alisma plantago-aquatica var.Orientale tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp.Root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var.Inermis fruit (saireito [alisma plantago-aquatica var.Orientale tuber;atractylodes lancea rhizome;bupleurum falcatum root;cinnamomum cassia bark;glycyrrhiza spp.Root;panax ginseng root;pinellia ternata tuber;polyporus umbellatus sclerotium;poria cocos sclerotium;) for keloid scar; loxoprofen sodium (loxoprofen na) for analgesic therapy; cefdinir (cefdinir) for infection prophylaxis; bupivacaine hydrochloride (marcain heavy) for anaesthesia procedure; ropivacaine hydrochloride (anapeine) for anaesthesia procedure; fentanyl (fentanyl) for anaesthesia procedure; metoclopramide hydrochloride (primperan) for vomiting; and oxytocin (atonin-o) for uterine contractions during pregnancy.[patient background] preoperative complications: none diabetes mellitus: none history of surgery: none past medical history: none allergy disposition: none family history: none smoking status: non-smoker alcohol use: unknown for pre-pregnancy period; no alcohol use during pregnancy and thereafter history of adverse reaction: none gravidity/parity: none [preoperative statuses] underlying disease: obstructed labour due to cephalo-pelvic disproportion patient's conditions: preoperative general health and nutrition condition, good; anaemia, no; radiotherapy, no [date of surgery and operative method] date of admission: (b)(6) 2018 date of discharge: (b)(6) 2018 (from this day, the patient was under the care of medical center b) date of surgery: (b)(6) 2018 (not prescheduled) anesthesia: lumbar anesthesia, extradural anesthesia operative/reconstruction method: caesarean section [application of seprafilm] application site: anterior wall of the uterus (infection at the application site: none) direct application to the anastomotic site: yes; number of the sheet, (qp) 4 sheets application condition: good operating surgeon's experience with seprafilm: yes (this patient was the 10th case).Indwelling drain: none pre-existing adhesion: none pre-existing intraperitoneal non-purulent inflammation: none pre-existing intraperitoneal infection: none intraperitoneal irrigation: none [anastomosis of the excision site] presence/absence of the excision site: absent pre-existing non-purulent inflammation: none pre-existing infection: none suture thread (type): inner layer (name: polysorb) absorbent, synthetic, and multi ligature (type): absorbent, synthetic, and multi condition of surgical field: aseptic (clean) surgery [suture of laparotomy wound] length of the laparotomy wound: 10 cm suture method of the first layer (peritoneum): continuous suture, suture thread: absorbent, synthetic, and multi (name: polysorb) method of suture of the skin: hand-stitch (continuous), suture thread: absorbent, synthetic, and mono pre-existing non-purulent inflammation: none pre-existing infection: none time of the surgery: about 40 minutes amount of bleeding: 620 g including amnion fluid blood transfusion: none [postoperative statuses] use of medical device along with seprafilm: none in case of the department of obstetrics and gynecology: none [facts relevant to the use of prostaglandin e2 for labor induction and as oxytocic] periodical measurement of mother's blood pressure: yes periodical measurement of mother's pulse: yes continuous use of delivery monitoring system: yes continuous monitoring of uterine contraction: yes continuous use of cardiotocography: yes painless labor: no on(b)(6) 2018, at 40 weeks and 4 days of pregnancy, the patient was admitted to the reporting hospital for induction of delivery.The patient received prophylactic antibacterial therapy with oral abpc (vaginal secretion biopsy at 36 weeks of pregnancy was negative for gbs).Because of weak labor (uterine inertia), the patient received prostaglandin e2 at a dose of 0.5 mg three times (at a dosing interval of one hour).On (b)(6) 2018, prostaglandin e2 was administered at a dose of 0.5 mg six times (at a dosing interval of one hour).On (b)(6) 2018, the patient began to have a labor pain spontaneously, which, however, did not progress.A diagnosis of obstructed labour due to cephalo-pelvic disproportion was made, and caesarean section was performed.Membrane rupture did not occur.The patient had no pyrexia.There was nothing suggestive of ascending infection from the vagina.During caesarean section, there was no pus in the intrauterine cavity and there was no foul smell, suggesting that there was no infection.Before the abdominal section, seprafilm was applied to the uterine wound and the anterior wall of uterus.Post-operative vital signs, body temperature, and state of bleeding indicated that the course after caesarean section was normal.The patient received antibacterial therapy with flumarin injection at a dose of 2 g/day on the day of surgery and on the following day.On (b)(6) 2018, on postoperative day (pod) 1, no abnormalities were observed.On (b)(6) 2018, on pod 3, transvaginal ultrasonography and cusco speculum examination showed no abnormalities.The tendency toward dehiscence of the epidermis was observed at the bottom edge of the caudal site of the wound, and it was again fixed with tape.On (b)(6) 2018, on pod 5, redness, induration, tenderness, and feeling hot around the wound were observed.The body temperature was 36.8 degrees centigrade.A blood test showed wbc 118180 and crp 10.Wound infection was suspected, and the antibacterial drug was changed to finibax.Bacterial culture was performed (specimen, lochia; targets, all aerobes and anaerobes), but no bacteria was detected.The events wound infection, peritonitis, and abscess developed (severity: moderate).The site of the peritonitis and the abscess apparently coincided with the seprafilm application site.On (b)(6) 2018, on pod 7, findings remained unchanged.The abdominal pain slightly increased.A blood test showed wbc 10300 and crp 12.3, and neither deterioration nor improvement was seen.Transvaginal ultrasound showed echo free space on the anterior surface of the uterus, which was suggestive of abscess formation.On this day, the patient was transferred to the department of obstetrics and gynecology of medical center b.On an unknown date, at medical center b, a re-laparotomy was performed and revealed abscess formation around the uterine wound.After the implementation of a partial resection of the myometrium and re-suturing, drainage was performed.Reportedly, the 4th bacterial culture test detected fungi, but contamination of the surgical field could not be denied.On an unknown date, the events wound infection, tenderness around the wound, feeling hot around the wound, redness around the wound, induration around the wound, peritonitis, and abscess resolved.The patient developed a serious peritonitis 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious wound infection (postoperative wound infection) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious abscess in uterine incision site (sterile abscess) (uterine abscess) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious redness around the wound (erythema) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious induration around the wound (induration) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious tenderness around the wound (tenderness) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious feeling hot around the wound (feeling hot) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.Relevant laboratory test results included: bacterial test - on (b)(6) 2018: [specimen: lochia targets: overall aerobes and anaerobes isolated bacteria: none]; on an unknown date: [the 4th bacterial culture reportedly detected fungi, but contamination of the surgical field could not be denied also.] body temperature - on (b)(6) 2018: 37.6 cel; on (b)(6) 2018: 38.0 cel; on (b)(6) 2018: 36.8 cel then 36.5 cel; on (b)(6) 2018: 37.0 cel; on (b)(6) 2018: 37.6 cel; on (b)(6) 2018: 37.2 cel c-reactive protein (0 - 0) - on (b)(6) 2018: 10 [10]; on (b)(6) 2018: 12.3 [12.3] culture - on an unknown date: negative [gbs negative] haematocrit (34.3 - 45 %) - on(b)(6) 2018: 37.3 %; on (b)(6) 2018: 31.7 %; on (b)(6) 2018: 32.9 %; on (b)(6) 2018 29.7 % haemoglobin (11.2 - 15.2 g/dl) - on (b)(6) 201811.6 g/dl; on (b)(6) 2018 10.8 g/dl; on (b)(6) 2018 10.4 g/dl; on (b)(6) 201810.0 g/dl platelet count (14 - 37 10*4/ul) - on (b)(6) 2018 29.1 10*4/ul; on (b)(6) 2018: 21.3 10*4/ul; on (b)(6) 2018 31.5 10*4/ul; on (b)(6) 2018 35.7 10*4/ul prothrombin time (10 - 13 second) - on (b)(6) 2018 11.8 second red blood cell count (376 - 516 10*4/ul) - on (b)(6) 2018 420 10*4/ul; on (b)(6) 2018: 37.9 10*4/ul; on (b)(6) 201838.2 10*4/ul; on (b)(6) 2018: 35.7 10*4/ul ultrasound scan vagina - on (b)(6) 2018: [echo free space on the anterior surface of the uterus was suggestive of abscess formation.] white blood cell count (3500 - 9700 /ul) - on(b)(6) 2018: 9280 /ul; on (b)(6) 2018: 17000 /ul; on (b)(6) 2018: 118180 /ul; on (b)(6) 2018: 10300 /ul final diagnosis was moderate abscess in uterine incision site (sterile abscess), moderate wound infection and moderate peritonitis.The patient was treated with doripenem (finibax).The patient outcome is reported as recovered / resolved on an unknown date for abscess in uterine incision site (sterile abscess), as recovered / resolved on an unknown date for peritonitis, as recovered / resolved on an unknown date for wound infection, as recovered / resolved on an unknown date for redness around the wound, as recovered / resolved on an unknown date for induration around the wound, as recovered / resolved on an unknown date for tenderness around the wound and as recovered / resolved on an unknown date for feeling hot around the wound.Additionally, at time of reporting, the patient delivered a baby at x weeks of gestation on 24-oct-18 (delivery type: cesarean).Outcome of the pregnancy was reported as full-term and fetal outcome was reported as normal/no defect.Reporter comment: [wound infection, peritonitis, abscess in uterine incision site (sterile abscess)] causal relationships to seprafilm: probable other possible causative factor: prostaglandin e2 (but this drug's contributory role was unlikely) causality of prostaglandin e2: not completely deniable because of the lack of evidence for "no relationship" inflammation due to chemical reaction involving seprafilm was strongly suspected, because no other infection-inducing factor was detected behind the abscess formation and also because no prophlogistic bacillus was found.Causal relationship to finibax (corrective treatment): unknown [abscess in uterine incision site (sterile abscess)] the causal relationship between this event and prostaglandin e2 was unlikely.But the causality of prostaglandin e2 is not completely deniable because of the lack of evidence for "no causal relationship".Seprafilm was a possible causative factor for the abscess in uterine incision site.This event required the patient to transfer to medical center b to undergo a re-laparotomy.Seprafilm-associated inflammation (chemical reaction) was strongly suspected to have induced this event because no other infection-inducing factor was detected behind the abscess formation and also because no prophlogistic bacillus was found.The causal relationship between finibax (corrective treatment) and this event was unknown.Additional information was received on 10-jun-2019: received investigation summary (investigation summary #216183, event id: 58831) additional information was received on 21-jun-2019 from the physician: changed prostaglandin e2 from concomitant drug to suspect drug, changed formulation and indication of prostaglandin e2, added pregnancy information, updated narrative, and updated reporter comment.Additional information was received on 24-jun-2019 from the physician: added lab data, added pregnancy information, updated concomitant drug information (indication, dosage), added concomitant drugs, changed the event term "abscess" to "abscess in uterine incision site (sterile abscess)", added reporter comment, and updated narrative.Additional information was received on 02-aug-2019 from the physician: updated dosage information of prostaglandin e2, updated narrative, and updated reporter comment.Corrections to the previous report: corrected race information, corrected lab data (wbc), corrected pregnancy information, and corrected indication of seprafilm.
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Event Description
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Peritonitis [peritonitis].Wound infection [postoperative wound infection] ([redness], [induration], [tenderness], [feeling hot]).Abscess in uterine incision site (sterile abscess) [uterine abscess].Case narrative: initial information received on 24-may-2019 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference:(b)(4) on 24-may-2019 and transmitted to sanofi.This case involves a 29 years old female patient (160 cm and 61 kg) who experienced peritonitis, wound infection and abscess in uterine incision site (sterile abscess), while she was treated with prostaglandin e2 and with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported peritonitis, wound infection, redness around the wound, induration around the wound, tenderness around the wound, feeling hot around the wound and abscess in uterine incision site (sterile abscess) 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 on (b)(6) 2018.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 obstructed labour and uterine hypotonus (severity before drug administration: mild), and was non-tobacco user.Notes: inpatient.Concomitant medications included amoxicillin hydrate (amoxicillin hydrate) for infection prophylaxis; flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis; diclofenac potassium (voltaren acti) for analgesic therapy; alisma plantago-aquatica var.Orientale tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp.Root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var.Inermis fruit (saireito [alisma plantago-aquatica var.Orientale tuber; atractylodes lancea rhizome; bupleurum falcatum root; cinnamomum cassia bark; glycyrrhiza spp.Root; panax ginseng root; pinellia ternata tuber; polyporus umbellatus sclerotium; poria cocos sclerotium;) for keloid scar; loxoprofen sodium (loxoprofen na) for analgesic therapy; cefdinir (cefdinir) for infection prophylaxis; bupivacaine hydrochloride (marcain heavy) for anaesthesia procedure; ropivacaine hydrochloride (anapeine) for anaesthesia procedure; fentanyl (fentanyl) for anaesthesia procedure; metoclopramide hydrochloride (primperan) for vomiting; and oxytocin (atonin-o) for uterine contractions during pregnancy.[patient background].Preoperative complications: none.Diabetes mellitus: none.History of surgery: none.Past medical history: none.Allergy disposition: none.Family history: none.Smoking status: non-smoker.Alcohol use: unknown for pre-pregnancy period; no alcohol use during pregnancy and thereafter.History of adverse reaction: none.Gravidity/parity: none.[preoperative statuses].Underlying disease: obstructed labour due to cephalo-pelvic disproportion patient's conditions: preoperative general health and nutrition condition, good; anaemia, no; radiotherapy, no.[date of surgery and operative method].Date of admission: on (b)(6) 2018.Date of discharge: on (b)(6) 2018 (from this day, the patient was under the care of (b)(6) b).Date of surgery: on (b)(6) 2018 (not prescheduled).Anesthesia: lumbar anesthesia, extradural anesthesia operative/reconstruction method: caesarean section.[application of seprafilm].Lot no.: unknown.Application site: anterior wall of the uterus (infection at the application site: none).Direct application to the anastomotic site: yes; number of the sheet, (qp) 4 sheets.Application condition: good.Operating surgeon's experience with seprafilm: yes (this patient was the 10th case).Indwelling drain: none.Pre-existing adhesion: none.Pre-existing intraperitoneal non-purulent inflammation: none.Pre-existing intraperitoneal infection: none.Intraperitoneal irrigation: none.[anastomosis of the excision site].Presence/absence of the excision site: absent.Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Suture thread (type): inner layer (name: polysorb) absorbent, synthetic, and multi.Ligature (type): absorbent, synthetic, and multi.Condition of surgical field: aseptic (clean) surgery.[suture of laparotomy wound].Length of the laparotomy wound: 10 cm.Suture method of the first layer (peritoneum): continuous suture, suture thread: absorbent, synthetic, and multi (name: polysorb).Method of suture of the skin: hand-stitch (continuous), suture thread: absorbent, synthetic, and mono.Pre-existing non-purulent inflammation: none.Pre-existing infection: none.Time of the surgery: about 40 minutes.Amount of bleeding: 620 g including amnion fluid.Blood transfusion: none.[postoperative statuses].Use of medical device along with seprafilm: none.In case of the department of obstetrics and gynecology: none.[facts relevant to the use of prostaglandin e2 for labor induction and as oxytocic].Periodical measurement of mother's blood pressure: yes.Periodical measurement of mother's pulse: yes.Continuous use of delivery monitoring system: yes.Continuous monitoring of uterine contraction: yes.Continuous use of cardiotocography: yes.Painless labor: no.On (b)(6) 2018, at 40 weeks and 4 days of pregnancy, the patient was admitted to the reporting hospital for induction of delivery.The patient received prophylactic antibacterial therapy with oral abpc (vaginal secretion biopsy at 36 weeks of pregnancy was negative for gbs).Because of weak labor (uterine inertia), the patient received prostaglandin e2 at a dose of 0.5 mg three times (at a dosing interval of one hour).On (b)(6) 2018, prostaglandin e2 was administered at a dose of 0.5 mg six times (at a dosing interval of one hour).On (b)(6) 2018, the patient began to have a labor pain spontaneously, which, however, did not progress.A diagnosis of obstructed labour due to cephalo-pelvic disproportion was made, and caesarean section was performed.Membrane rupture did not occur.The patient had no pyrexia.There was nothing suggestive of ascending infection from the vagina.During caesarean section, there was no pus in the intrauterine cavity and there was no foul smell, suggesting that there was no infection.Before the abdominal section, seprafilm was applied to the uterine wound and the anterior wall of uterus.Post-operative vital signs, body temperature, and state of bleeding indicated that the course after caesarean section was normal.The patient received antibacterial therapy with flumarin injection at a dose of 2 g/day on the day of surgery and on the following day.On (b)(6) 2018, on postoperative day (pod) 1, no abnormalities were observed.On (b)(6) 2018, on pod 3, transvaginal ultrasonography and cusco speculum examination showed no abnormalities.The tendency toward dehiscence of the epidermis was observed at the bottom edge of the caudal site of the wound, and it was again fixed with tape.On (b)(6) 2018, on pod 5, redness, induration, tenderness, and feeling hot around the wound were observed.The body temperature was 36.8 degrees centigrade.A blood test showed wbc 118180 and crp 10.Wound infection was suspected, and the antibacterial drug was changed to finibax.Bacterial culture was performed (specimen, lochia; targets, all aerobes and anaerobes), but no bacteria was detected.The events wound infection, peritonitis, and abscess developed (severity: moderate).The site of the peritonitis and the abscess apparently coincided with the seprafilm application site.On (b)(6) 2018, on pod 7, findings remained unchanged.The abdominal pain slightly increased.A blood test showed wbc 10300 and crp 12.3, and neither deterioration nor improvement was seen.Transvaginal ultrasound showed echo free space on the anterior surface of the uterus, which was suggestive of abscess formation.On this day, the patient was transferred to the (b)(6) b.On an unknown date, at (b)(6) b, a re-laparotomy was performed and revealed abscess formation around the uterine wound.After the implementation of a partial resection of the myometrium and re-suturing, drainage was performed.Reportedly, the 4th bacterial culture test detected fungi, but contamination of the surgical field could not be denied.On an unknown date, the events wound infection, tenderness around the wound, feeling hot around the wound, redness around the wound, induration around the wound, peritonitis, and abscess resolved.The patient developed a serious peritonitis 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious wound infection (postoperative wound infection) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious abscess in uterine incision site (sterile abscess) (uterine abscess) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious redness around the wound (erythema) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious induration around the wound (induration) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious tenderness around the wound (tenderness) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.The patient developed a serious feeling hot around the wound (feeling hot) 6 days following the first dose intake and 6 days following the last dose intake of prostaglandin e2.This event was assessed as medically significant and was leading to intervention.Due to this event patient's hospitalization was prolonged.Relevant laboratory test results included: bacterial test: on (b)(6) 2018: [specimen: lochia.Targets: overall aerobes and anaerobes.Isolated bacteria: none]; on an unknown date: [the 4th bacterial culture reportedly detected fungi, but contamination of the surgical field could not be denied also].Body temperature: on (b)(6) 2018: 37.6 cel; on (b)(6) 2018: 38 cel; on (b)(6) 2018: 36.8 cel then 36.5 cel; on (b)(6) 2018: 37 cel; on (b)(6) 2018: 37.6 cel; on (b)(6) 2018: 37.2 cel c-reactive protein (0 - 0 unk); on (b)(6) 2018: 10 unk [10]; on (b)(6) 2018: 12.3 unk [12.3].Culture: on an unknown date: negative [gbs negative].Haematocrit (34.3 - 45 %) on (b)(6) 2018: 37.3 %; on (b)(6) 2018: 31.7 %; on (b)(6) 2018: 32.9 %; on (b)(6) 2018: 29.7 %; haemoglobin (11.2 - 15.2 g/dl); on (b)(6) 2018: 11.6 g/dl; on (b)(6) 2018: 10.8 g/dl; on (b)(6) 2018: 10.4 g/dl; on (b)(6) 2018: 10 g/dl; platelet count (14 - 37 10 4/ul); on (b)(6) 2018: 29.1 10 4/ul; on (b)(6) 2018: 21.3 10 4/ul; on (b)(6)2018: 31.5 10 4/ul; on (b)(6) 2018: 35.7 10 4/ul; prothrombin time (10 - 13 second); on (b)(6) 2018: 11.8 second red blood cell count (376 - 516 10 4/ul); on (b)(6) 2018: 420 10 4/ul; on (b)(6) 2018: 37.9 10 4/ul; on (b)(6) 2018: 38.2 10 4/ul; on (b)(6) 2018: 35.7 10 4/ul; ultrasound scan vagina on (b)(6) 2018: [echo free space on the anterior surface of the uterus was suggestive of abscess formation].White blood cell count (3500 - 9700 /ul) on (b)(6) 2018: 9280 /ul; on (b)(6) 2018: 17000 /ul; on (b)(6) 2018: 118180 /ul; on (b)(6) 2018: 10300 /ul.Final diagnosis was moderate abscess in uterine incision site (sterile abscess), moderate wound infection and moderate peritonitis.The patient was treated with doripenem (finibax).The patient outcome is reported as recovered / resolved on an unknown date for abscess in uterine incision site (sterile abscess), as recovered / resolved on an unknown date for peritonitis, as recovered / resolved on an unknown date for wound infection, as recovered / resolved on an unknown date for redness around the wound, as recovered / resolved on an unknown date for induration around the wound, as recovered / resolved on an unknown date for tenderness around the wound and as recovered / resolved on an unknown date for feeling hot around the wound.Additionally, at time of reporting, the patient delivered a baby at x weeks of gestation on (b)(6) 2018 (delivery type: cesarean).Outcome of the pregnancy was reported as full-term and fetal outcome was reported as normal/no defect.Reporter comment: [wound infection, peritonitis, abscess in uterine incision site (sterile abscess)].Causal relationships to seprafilm: probable.Other possible causative factor: prostaglandin e2 (but this drug's contributory role was unlikely).Causality of prostaglandin e2: not completely deniable because of the lack of evidence for "no relationship".Inflammation due to chemical reaction involving seprafilm was strongly suspected, because no other infection-inducing factor was detected behind the abscess formation and also because no prophlogistic bacillus was found.Causal relationship to finibax (corrective treatment): unknown.[abscess in uterine incision site (sterile abscess)].The causal relationship between this event and prostaglandin e2 was unlikely.But the causality of prostaglandin e2 is not completely deniable because of the lack of evidence for "no causal relationship".Seprafilm was a possible causative factor for the abscess in uterine incision site.This event required the patient to transfer to (b)(6) b to undergo a re-laparotomy.Seprafilm-associated inflammation (chemical reaction) was strongly suspected because there was few infection-inducing factors behind the abscess formation and also because no prophlogistic bacillus was found.The causal relationship between finibax (corrective treatment) and this event was unknown.Additional information was received on 10-jun-2019: received investigation summary (investigation summary#: (b)(4).Additional information was received on 21-jun-2019 from the physician: changed prostaglandin e2 from concomitant drug to suspect drug, changed formulation and indication of prostaglandin e2, added pregnancy information, updated narrative, and updated reporter comment.Additional information was received on 24-jun-2019 from the physician: added lab data, added pregnancy information, updated concomitant drug information (indication, dosage), added concomitant drugs, changed the event term "abscess" to "abscess in uterine incision site (sterile abscess)", added reporter comment, and updated narrative.Additional information was received on 02-aug-2019 from the physician: updated dosage information of prostaglandin e2, updated narrative, and updated reporter comment.Corrections to the previous report: corrected race information, corrected lab data (wbc), corrected pregnancy information, and corrected indication of seprafilm.Additional information was received on 24-may-2019 from the physician (local pv received on 15-jan-2020): updated reporter information, updated reporter comment (the statement "seprafilm-associated inflammation (chemical reaction) was strongly suspected because no other infection-inducing factor was detected behind the abscess formation" was changed to "seprafilm-associated inflammation (chemical reaction) was strongly suspected because there was few infection-inducing factors behind the abscess formation"), and added "lot number, unknown" to narrative.
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