| Device Problems
Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Failure to Anastomose (1028); Unspecified Infection (1930)
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| Event Date 07/12/2009 |
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Event Type
Injury
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Event Description
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Surgical-site infection (wound infection: muscle layer) [surgical site infection], ([redness], [suture rupture]).Case narrative: initial information received on 21-aug-2019 regarding a solicited valid serious case received from (lp) (b)(6)-pcp under reference on 31-jan-2020 and transmitted to sanofi, in the scope of post-marketing sponsored study.Literature information author: saito g, sadahiro s, ogimi t, miyakita h, okada k, tanaka a, et al.Title: preventive effects of a synthetic absorbable antiadhesive film (seprafilm) on small bowel obstruction in patients who underwent elective surgery for colon cancer: a randomized controlled trial.Journal: journal of surgical oncology 2019; unk: 1-6.Center id: unk; patient id: unk; country: japan.Study title: unsponsored study involving seprafilm.This case was issued in publication in which 3 other related cases were reported: (b)(4) (cluster).This case involves a (b)(6) years old female patient (144 cm and (b)(6) kg) who experienced surgical-site infection (wound infection: muscle layer), while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included colon cancer.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 cardiac failure since 2006 and anaemia, and was non-tobacco user.Notes: inpatient.[patient background].Underlying disease: colon cancer.Diabetes mellitus: none.Allergic factor: none.History of surgery: none.[before surgery].Patient's condition: condition before surgery: complication of severe systemic disease.Nutritional status: poor.Anaemia: yes.Radiation therapy: none.[date and method of surgery].Hospitalization date: (b)(6) 2009, discharge date: (b)(6) 2009.Surgery date: (b)(6) 2009 (elective surgery).Intraoperative hyperthermia: none.Application site: right below midline wound (infection of application site: none).Direct application to anastomosis site: none, application status: favorable.Does the surgeon have any experiences of using seprafilm: yes.Operative status: removal of the left half of colon, application of seprafilm right below the wound, middle wound ssi, wound disruption, and no drainage.Pre-existing adhesion: none, detachment: none.Intraperitoneal pre-existing non-purulent.Inflammation: none, pre-existing infection: none, intraperitoneal irrigation: yes (3 l) [anastomosis of resection site].Resection site: yes: transverse colon, pre-existing infection: none, intraperitoneal pre-existing non-purulent inflammation: none,method of anastomosis: hand suture (knotted), suture thread used for anastomosis (type): absorbable, multi thread (name: 3-ovicny), ligature (type): absorbable, multi thread (name: 3-ovicny).Status of operative field: clean-contaminated operation: incision of digestive tract: yes.[suture of laparotomy incision].Length of laparotomy incision: 25 cm, layer of sutures: 2 layers.Method of the 1st layer (peritoneum) suture: knotted, suture thread: absorbable, mono thread (name: opds).Method of skin suture: hand suture (knotted), suture thread: absorbable, mono thread (name: 4-opds).Intraperitoneal pre-existing non-purulent inflammation: none, pre-existing infection: none operative duration: about 2 hours, volume of bleeding: 113 g, blood transfusion: none [after surgery].Combination use of other medical device: none.[examination/treatment for the event].Bacterial culture: not performed.Infection/inflammation-related laboratory test results: wbc: 7500, crp: 4.69 (test date: (b)(6) 2009).Prolonged hospitalization: yes.Re-hospitalization for treatment: none.Re-laparotomy: performed ((b)(6) 2009).Status at the time of re-laparotomy: status of seprafilm: seprafilm had been completely absorbed in the body.Removal of seprafilm: not removed, other treatment: none.Concomitant medications included flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis.On (b)(6) 2009, 2 sheets of seprafilm (lot number: unknown) were used for left hemicolectomy.On (b)(6) 2009, 6 pod (postoperative day), the patient had surgical-site infection (wound infection: muscle layer), suture failure and wound redness.Re-closure was performed.Symptoms of cardiac failure prolonged.After re-laparotomy, the event was resolving.On (b)(6) 2009, the patient recovered from surgical-site infection (wound infection: muscle layer), suture failure and wound redness.The patient was discharged.On (b)(6) 2016, the patient died of cardiac failure.The patient developed an event of a serious surgical-site infection (wound infection: muscle layer) (postoperative wound infection).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) 2009 (hospitalization during 43 days).The patient developed an event of a serious suture failure (suture rupture).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) 2009 (hospitalization during 43 days).The patient developed an event of a serious wound redness (erythema).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) 2009 (hospitalization during 43 days).Relevant laboratory test results included: c-reactive protein - on (b)(6) 2009: 4.69 [4.69].White blood cell count - on (b)(6) 2009: 7500 [7500].Final diagnosis was moderate surgical-site infection (wound infection: muscle layer).It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on (b)(6) 2009 for suture failure, as recovered / resolved on (b)(6) 2009 for surgical-site infection (wound infection: muscle layer) and as recovered / resolved on (b)(6) 2009 for wound redness.Postoperative wound infection is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Suture rupture is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Erythema is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: [surgical-site infection (wound infection: muscle layer)].Causal relationship between the event and seprafilm: unknown.Possible causative factor for the event other than seprafilm: the patient's risk factors (concurrent condition, historical condition, age, etc.).Additional information was received on 29-aug-2019: received investigation summary (investigation summary #(b)(4), event id: (b)(4)), added reporter information, and added company comment.Correction to the previous report: corrected race information.Additional information was received on 06-sep-2019: no new information was received.Amendment to the report dated 29-aug-2019: added events of "respiratory complications" and "cardiovascular complications".Additional information was received on 31-jan-2020 from the physician: deleted "cardiovascular complications" and "respiratory complications" from the adverse events; added patient information and other relevant history; added a concomitant drug; added reporter comment; updated clinical course; changed the event term from "surgical-site infection" to "surgical-site infection (wound infection: muscle layer)" and updated information on the event (onset date, outcome date, and outcome); changed the event "suture failure" from diagnosis to a symptom; added an event "wound redness".
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Event Description
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Surgical-site infection (wound infection: muscle layer) [surgical site infection] ([suture rupture], [redness]).Case narrative: initial information received on 21-aug-2019 regarding a solicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 27-mar-2020 and transmitted to sanofi, in the scope of post-marketing sponsored study.Literature information: author: saito g, sadahiro s, ogimi t, miyakita h, okada k, tanaka a, et al.Title: preventive effects of a synthetic absorbable antiadhesive film (seprafilm) on small bowel obstruction in patients who underwent elective surgery for colon cancer: a randomized controlled trial.Journal: journal of surgical oncology 2019; unk: 1-6.Center id: unk; patient id: unk; country: japan.Study title: unsponsored study involving seprafilm.This case was issued in publication in which 3 other related cases were reported: (b)(4)(cluster).This case involves a 82 years old female patient (144 cm and 46 kg) who experienced surgical-site infection (wound infection: muscle layer), while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included colon cancer.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 cardiac failure since 2006 and anaemia, and was non-tobacco user.Notes: inpatient.[patient background]: underlying disease: colon cancer.Diabetes mellitus: none.] allergic factor: none.History of surgery: none.[before surgery]: patient's condition: condition before surgery: complication of severe systemic disease nutritional status: poor.Anaemia: yes.Radiation therapy: none.[date and method of surgery].Hospitalization date: (b)(6) 2009, discharge date: (b)(6) 2009.Surgery date: (b)(6) 2009 (elective surgery).Intraoperative hyperthermia: none.Application site: right below midline wound (infection of application site: none).Direct application to anastomosis site: none, application status: favorable.Does the surgeon have any experiences of using seprafilm: yes.Operative status: removal of the left half of colon, application of seprafilm right below the wound, middle wound ssi, wound disruption, and no drainage.Pre-existing adhesion: none, detachment: none.Intraperitoneal pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: yes (3 l) [anastomosis of resection site].Resection site: yes: transverse colon, pre-existing infection: none, intraperitoneal pre-existing non-purulent inflammation: none,method of anastomosis: hand suture (knotted), suture thread used for anastomosis (type): absorbable, multi thread (name: 3-ovicny), ligature (type): absorbable, multi thread (name: 3-ovicny).Status of operative field: clean-contaminated operation: incision of digestive tract: yes [suture of laparotomy incision].Length of laparotomy incision: 25 cm, layer of sutures: 2 layers method of the 1st layer (peritoneum) suture: knotted, suture thread: absorbable, mono thread (name: opds).Method of skin suture: hand suture (knotted), suture thread: absorbable, mono thread (name: 4-opds).Intraperitoneal pre-existing non-purulent inflammation: none, pre-existing infection: none operative duration: about 2 hours, volume of bleeding: 113 g, blood transfusion: none [after surgery].Combination use of other medical device: none.[examination/treatment for the event].Bacterial culture: not performed.Infection/inflammation-related laboratory test results: wbc: 7500, crp: 4.69 (test date: (b)(6) 2009).Prolonged hospitalization: yes.Re-hospitalization for treatment: none.Re-laparotomy: performed ((b)(6) 2009).Status at the time of re-laparotomy: status of seprafilm: seprafilm had been completely absorbed in the body.Removal of seprafilm: not removed, other treatment: none.Concomitant medications included flomoxef sodium (flumarin [flomoxef sodium]) for infection prophylaxis.On (b)(6) 2009, 2 sheets of seprafilm (lot number: unknown) were used for left hemicolectomy.On (b)(6) 2009, 6 pod (postoperative day), the patient had surgical-site infection (wound infection: muscle layer), suture failure and wound redness.Re-closure was performed.Symptoms of cardiac failure prolonged.After re-laparotomy, the event was resolving.Treatment: the physician did not remember specifically.Test results relevant to wound infection: none on (b)(6) 2009, the patient recovered from surgical-site infection (wound infection: muscle layer), suture failure and wound redness.The patient was discharged.On (b)(6) 2016, the patient died of cardiac failure.It was unknown if an autopsy was performed.Information on the clinical course from the onset of the adverse reactions to death: unknown.The patient developed an event of a serious surgical-site infection (wound infection: muscle layer) (postoperative wound infection).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) 2009 (hospitalization during 43 days).The patient developed an event of a serious suture failure (suture rupture).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) 2009 (hospitalization during 43 days).The patient developed an event of a serious wound redness (erythema).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) 2009 (hospitalization during 43 days).Relevant laboratory test results included: c-reactive protein - on (b)(6) 2009: 4.69 unk [4.69].White blood cell count - on (b)(6) 2009: 7500 unk [7500].Final diagnosis was moderate surgical-site infection (wound infection: muscle layer).It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on (b)(6) 2009 for suture failure, as recovered / resolved on (b)(6) 2009 for surgical-site infection (wound infection: muscle layer) and as recovered / resolved on (b)(6) 2009 for wound redness.Postoperative wound infection is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Suture rupture is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Erythema is considered to be unassessable to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: [surgical-site infection (wound infection: muscle layer)].Causal relationship between the event and seprafilm: unknown.Possible causative factor for the event other than seprafilm: the patient's risk factors (there was no specific factor in concurrent condition, historical condition, age, etc.).Additional information was received on 29-aug-2019: received investigation summary (investigation summary #(b)(4), event id: (b)(6) ), added reporter information, and added company comment.Correction to the previous report: corrected race information.Additional information was received on 06-sep-2019: no new information was received.Amendment to the report dated 29-aug-2019: added events of "respiratory complications" and "cardiovascular complications".Additional information was received on 31-jan-2020 from the physician: deleted "cardiovascular complications" and "respiratory complications" from the adverse events; added patient information and other relevant history; added a concomitant drug; added reporter comment; updated clinical course; changed the event term from "surgical-site infection" to "surgical-site infection (wound infection: muscle layer)" and updated information on the event (onset date, outcome date, and outcome); changed the event "suture failure" from diagnosis to a symptom; added an event "wound redness".Additional information was received on 27-mar-2020 from the physician: updated clinical course and reporter comment.Local comments: *downgrade*.
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