| Lot Number 15NP569, 15NP605 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abnormal Blood Gases (1034); Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932)
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| Event Date 09/03/2016 |
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Event Type
Injury
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Event Description
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Based upon additional information received on 21-sep-2016, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added for the events of abdominal pain, inflammation and platelets decreased.This unsolicited case from (b)(6) was received on 09-sep-2016 from a pharmacist.This case involves a (b)(6) male patient who had placement of seprafilm and after 1 day had abdominal pain and platelets decreased and after 2 days had inflammation.The underlying disease (surgery indication) was adhesive ileus.The patient had no concurrent condition before surgery.No past drug was reported.On (b)(6) 2016, small intestinal resection was performed for adhesive for ileus and 1 sheet of seprafilm was applied to the small intestinal resection site (form, route, frequency, indication and expiry date: not provided; batch/ lot numbers: 15np569 and 15np605).The other concomitantly used medical devices included endo gia tri-staple 60amc, pgia60amt, and balloon, circle 20g.Sepralap was not used.On (b)(6) 2016, 1 day after seprafilm placement, the patient had severe abdominal pain, pyrexia, increased c-reactive protein (crp) (20 mg/dl), and severe decreased platelets after the surgery.It was reported that the onset site seemed obvious to be the application site of seprafilm or was unknown (systemic inflammation; blood test data).On (b)(6) 2016, two days after the placement, moderate inflammation was noted in the intraperitoneal area (localised), and the onset site seemed obvious to be the application site of seprafilm.Re-laparotomy was performed on the day, and irrigation was performed for the event because causal relationship was suspected.It was reported that causal relationship was suspected and irrigation was performed.On (b)(6) 2016, patient's symptoms and laboratory data improved.As of (b)(6) 2016, the patient was recovering from all the events.Corrective treatment: irrigation for inflammation; not reported for rest of the events.Outcome: recovering/ resolving for all events.Diagnosis: abdominal pain.Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization) reporting surgeon's causality assessment: unknown.Diagnosis: pyrexia.Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: crp increased to 20 mg/dl.Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: platelets decreased.Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: inflammation (inflammation localised).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Additional information was received on 21-sep-2016 from a physician (surgeon).The medical history and concomitantly used medical devices were added.The verbatim for the symptom of crp increased was updated to crp increased to 20 mg/dl.The lot numbers of seprafilm were added.The onset date for abdominal pain and pyrexia was updated from (b)(6) 2016.The outcome for abdominal pain, pyrexia, crp increased to 20 mg/dl, and platelets decreased was provided as recovering as of (b)(6) 2016.The reporter's seriousness assessment of hospitalization and the causality assessment for abdominal pain, pyrexia, crp increased to 20 mg/dl and platelets decreased were added and the case was upgraded to serious.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 21-sep-2016: this case concerns a male patient who underwent small intestinal resection for adhesive ileus and sheet of seprafilm was applied to this site and later on hospitalized for abdominal pain, pyrexia, c-reactive protein increased, decreased platelets and inflammation at the application site.Since a significant temporal relationship can be established the causal role of suspect cannot be denied in occurrence of the event.Furthermore, due to limited information regarding underlying concurrent medic.
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Event Description
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Based upon additional information received on 21-sep- 2016, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added for the events of abdominal pain, inflammation and platelets decreased.This unsolicited case from (b)(6) was received on (b)(6) 2016 from a pharmacist.This case involves a (b)(6) male patient who had placement of seprafilm and after 1 day had abdominal pain and platelets decreased and after 2 days had inflammation.The underlying disease (surgery indication) was adhesive ileus.The patient had no concurrent condition before surgery.No past drug was reported.On (b)(6) 2016, small intestinal resection was performed for adhesive for ileus and 1 sheet of seprafilm was applied to the small intestinal resection site (form, route, frequency, indication and expiry date: not provided; batch/ lot numbers: 15np569 or 15np605).The other concomitantly used medical devices included endo gia tri-staple 60amc, pgia60amt, and balloon, circle 20g.Sepralap was not used.On (b)(6) 2016, 1 day after seprafilm placement, the patient had severe abdominal pain, pyrexia, increased c-reactive protein (crp) (20 mg/dl), and severe decreased platelets after the surgery.It was reported that the onset site seemed obvious to be the application site of seprafilm or was unknown (systemic inflammation; blood test data).On (b)(6) 2016, two days after the placement, moderate inflammation was noted in the intraperitoneal area (localised), and the onset site seemed obvious to be the application site of seprafilm.Re-laparotomy was performed on the day, and irrigation was performed for the event because causal relationship was suspected.It was reported that causal relationship was suspected and irrigation was performed.On (b)(6) 2016, patient's symptoms and laboratory data improved.As of (b)(6) 2016, the patient was recovering from all the events.Corrective treatment: irrigation for inflammation; not reported for rest of the events.Outcome: recovering/ resolving for all events.Diagnosis: abdominal pain (abdominal pain).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: pyrexia (pyrexia).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: crp increased to 20 mg/dl (crp increased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: platelets decreased (platelets decreased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: inflammation (inflammation localised).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).No product lot number was provided by the reporter; therefore genzyme biosurgery quality assurance was unable to perform a specific lot history review/investigation in response to this event.All seprafilm lots manufactured by genzyme were released for shipment by quality assurance only after successful completion of quality control certificate of analysis testing and review of all device history records and associated manufacturing process documentation.This lot release procedure provides assurance that all product lots are manufactured under specified process parameters and pass final product specifications.Seprafilm adhesion barrier is packaged in a tyvek holder within a plastic sleeve and sealed in an outer foil pouch.The contents of the foil pouch are sterilized by gamma radiation.Product safety metrics are compiled by genzyme/sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal would be discussed during these trending meetings and escalated to the safety governance for adjudication.If a lot number for this event is reported at a later date, this product event will be reopened and an investigation will be performed by genzyme-sanofi biosurgery quality assurance at that time.Additional information was received on (b)(6) 2016 from a physician (surgeon).The medical history and concomitantly used medical devices were added.The verbatim for the symptom of crp increased was updated to crp increased to 20 mg/dl.The lot numbers of seprafilm were added.The onset date for abdominal pain and pyrexia was updated from (b)(6) 2016.The outcome for abdominal pain, pyrexia, crp increased to 20 mg/dl, and platelets decreased was provided as recovering as of (b)(6) 2016.The reporter's seriousness assessment of hospitalization and the causality assessment for abdominal pain, pyrexia, crp increased to 20 mg/dl and platelets decreased were added and the case was upgraded to serious.Clinical course updated and text amended accordingly.Additional information was received on 06-oct-2016.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 06-oct-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 21-sep-2016: this case concerns a male patient who underwent small intestinal resection for adhesive ileus and sheet of seprafilm was applied to this site and later on hospitalized for abdominal pain, pyrexia, c-reactive protein increased, decreased platelets and inflammation at the application site.Since a significant temporal relationship can be established the causal role of suspect cannot be denied in occurrence of the event.Furthermore, due to limited information regarding underlying concurrent medical conditions, concomitant medication and past drugs complete medical assessment of the case is difficult.
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Event Description
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Based upon additional information received on 12-oct- 2016, this case initially processed as unsolicited case is now considered as unsolicited from health authority case.Based upon additional information received on 21-sep- 2016, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added for the events of abdominal pain, inflammation and platelets decreased.This unsolicited case from (b)(6) was received on 09-sep-2016 from a pharmacist.This case involves a (b)(6) male patient who had placement of seprafilm and after 1 day had abdominal pain and platelets decreased and after 2 days had localised inflammation of the intraperitoneal area.The underlying disease (surgery indication) was adhesive ileus.The patient had no concurrent condition before surgery.No past drug was reported.On (b)(6) 2016 (at 10:00), small intestinal resection was performed for adhesive for ileus and 1 sheet of seprafilm was applied to the small intestinal resection site by the physician (form, route, frequency and expiry date: not provided; batch/ lot numbers: 15np569 or 15np605) for avoidance of adhesion of the intraperitoneal area immediately below the surgical wound to the organ.The other concomitantly used medical devices included endo gia tri-staple 60amc, pgia60amt, and balloon, circle 20g.Sepralap was not used.On (b)(6) 2016, 1 day after seprafilm placement, the patient had severe abdominal pain, pyrexia, increased c-reactive protein (crp) (20 mg/dl), and severe decreased platelets after the surgery.It was reported that the onset site seemed obvious to be the application site of seprafilm or was unknown (systemic inflammation; blood test data).On (b)(6) 2016, two days after the placement, moderate inflammation was noted in the intraperitoneal area (localised), and the onset site seemed obvious to be the application site of seprafilm.Re-laparotomy was performed on the day, and irrigation was performed for the event because causal relationship was suspected.It was reported that causal relationship was suspected and irrigation was performed.On (b)(6) 2016, patient's symptoms and laboratory data improved.On (b)(6) 2016, blood test data showed the improvement of crp and platelets to 8.5 mg/dl and 37.6 x 10000/mcl, respectively.The body temperature was 36.8 degree celsius and his pain also improved.As of (b)(6) 2016, the patient was recovering from all the events.On (b)(6) 2016, his condition improved and was discharged from the hospital.Corrective treatment: irrigation for inflammation; not reported for rest of the events.Outcome: recovering/ resolving for all events.Diagnosis: abdominal pain (abdominal pain).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: pyrexia (pyrexia).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: crp increased to 20 mg/dl (crp increased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: platelets decreased (platelets decreased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: localised inflammation of the intraperitoneal area (gastrointestinal inflammation).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.The attending physician's comment: the patient was suspected to have hypersensitivity to a component of seprafilm.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).No product lot number was provided by the reporter; therefore genzyme biosurgery quality assurance was unable to perform a specific lot history review/investigation in response to this event.All seprafilm lots manufactured by genzyme were released for shipment by quality assurance only after successful completion of quality control certificate of analysis testing and review of all device history records and associated manufacturing process documentation.This lot release procedure provides assurance that all product lots are manufactured under specified process parameters and pass final product specifications.Seprafilm adhesion barrier is packaged in a tyvek holder within a plastic sleeve and sealed in an outer foil pouch.The contents of the foil pouch are sterilized by gamma radiation.Product safety metrics are compiled by genzyme/sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal would be discussed during these trending meetings and escalated to the safety governance for adjudication.If a lot number for this event is reported at a later date, this product event will be reopened and an investigation will be performed by genzyme-sanofi biosurgery quality assurance at that time.Additional information was received on 21-sep-2016 from a physician (surgeon).The medical history and concomitantly used medical devices were added.The verbatim for the symptom of crp increased was updated to crp increased to 20 mg/dl.The lot numbers of seprafilm were added.The onset date for abdominal pain and pyrexia was updated from 01-sep-2016 to 02-sep-2016.The outcome for abdominal pain, pyrexia, crp increased to 20 mg/dl, and platelets decreased was provided as recovering as of 09-sep-2016.The reporter's seriousness assessment of hospitalization and the causality assessment for abdominal pain, pyrexia, crp increased to 20 mg/dl and platelets decreased were added and the case was upgraded to serious.Clinical course updated and text amended accordingly.Additional information was received on 06-oct-2016.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 12-oct-2016 from pharmacist via health authority (reference number: (b)(4)).Product indication was added.Event verbatim was updated from inflammation to localised inflammation of the intraperitoneal area.Hospital discharge date for all the events was added.Laboratory investigations were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 12-oct-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 21-sep-2016: this case concerns a male patient who underwent small intestinal resection for adhesive ileus and sheet of seprafilm was applied to this site and later on hospitalized for abdominal pain, pyrexia, c-reactive protein increased, decreased platelets and inflammation at the application site.Since a significant temporal relationship can be established the causal role of suspect cannot be denied in occurrence of the event.Furthermore, due to limited information regarding underlying concurrent medical conditions, concomitant medication and past drugs complete medical assessment of the case is difficult.
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Event Description
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Based upon additional information received on 12-oct- 2016, this case initially processed as unsolicited case is now considered as unsolicited from health authority case.Based upon additional information received on 21-sep- 2016, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of hospitalization was added for the events of abdominal pain, inflammation and platelets decreased.This unsolicited case from (b)(6) was received on 09-sep-2016 from a pharmacist.This case involves a (b)(6) male patient who had placement of seprafilm and after 2 days had peritonitis.The underlying disease (surgery indication) was adhesive ileus.The patient had no concurrent condition before surgery.The medical history was significant for pneumothorax and bronchial asthma.The history of surgery included appendicitis and adhesive ileus at the age of (b)(6) and total prostatectomy for prostate cancer in 2011.The patient was an ex-smoker from the age of (b)(6) (30 cigarettes/ day).The preoperative condition was generally healthy and nutrition status was good.There was no anaemia and the patient had not received radiotherapy.No past drug was reported.The concomitant drug was cefmetazole as prophylaxis of postoperative infection.On (b)(6) 2016, the patient visited the reporting hospital with abdominal pain as a chief complaint.The abdominal computerized tomography (ct) scan showed ileus, and contrast-enhanced ct showed formation of a closed loop, and the patient was hospitalized on (b)(6) 2016.On (b)(6) 2016 the patient underwent release of ileus and at 10:00, small intestinal resection was performed for adhesive for ileus and 4 sheets of seprafilm were applied to the small intestinal resection site by the physician (form, route, frequency and expiry date: not provided; batch/ lot numbers: 15np569 or 15np605) for avoidance of adhesion of the intraperitoneal area immediately below the surgical wound to the organ which was not an elective surgery.Hyperthermic therapy was performed during the surgery.The condition of application was favorable.The operating surgeon was experienced in using seprafilm.No pre-existing adhesion was observed and adhesiolysis was not performed during the surgery.No pre-existing non-purulent inflammation or infection was observed in the peritoneal cavity.Intraperitoneal irrigation was not performed.It was reported that obstruction of the anastomosis loop site (small intestinal side) of the previous surgery was noted, and approximately 10 cm of the small intestine including the looped ileum was resected.Seprafilm was used when the wound was closed.No pre-existing nonpurulent inflammation or infection was observed in the resection sites.The resection sites were anastomosed with a machine.The outer layer was sutured with black silk (non-absorbable thread).The ligature was nonabsorbable thread (silk).Operative field was clean.The length of laparotomy incision was 10 cm, and involved saturation of 3 layers.The first layer (peritoneum) was sutured with absorbable thread (continuous suture).The skin was stapled with skin stapler and was sutured with non-absorbable thread (3-0 nylon).No pre-existing non-purulent inflammation or infection was observed in the laparotomy incision site.No other medical device was used concomitantly after the surgery.Sepralap was not used.No drainage tube was placed.On (b)(6) 2016, 1 day after seprafilm placement, the patient had severe abdominal pain, pyrexia, increased c-reactive protein (crp) (20 mg/dl), and severe decreased platelets after the surgery.It was reported that pyrexia of 40 degree c, increased crp, and increased white blood cells (wbcs) were noted after the surgery, however, abdominal ct showed no intraperitoneal abscess, and no apparent source of the pyrexia was indicated.It was reported that the onset site seemed obvious to be the application site of seprafilm or was unknown (systemic inflammation; blood test data).On (b)(6) 2016, two days after the placement, moderate peritonitis (confirmed with ct scan) developed, and the onset site seemed obvious to be the application site of seprafilm.The wbc count was 21100/mcl and crp was 21.3 mg/dl.Investigational re-laparotomy was performed on the day, and irrigation was performed for the event because causal relationship was suspected.It was reported that causal relationship was suspected and irrigation was performed.The small intestine-to-small intestine anastomosis site and the sigmoid colon injury correction site of previous surgery showed no failure of the sutures and were normal.Residual gelled seprafilm was noted and removed.As cloudy serous ascites was observed, the intraperitoneal area was adequately irrigated with normal saline and a pleated drain was inserted to douglas' pouch, and the surgery was ended.The events remarkably improved after this surgery.The patient received treatment with meropenem (intravenous, 1 g/day, from (b)(6) 2016) for prophylaxis of postoperative infection.On (b)(6) 2016, patient's symptoms and laboratory data improved.On (b)(6) 2016, blood test data showed the improvement of crp and platelets to 8.5 mg/dl and 37.6 x 10000/mcl, respectively.The body temperature was 36.8 degree celsius and his pain also improved.As of (b)(6) 2016, the patient was recovering from all the events.Improvement of inflammation findings was observed after the surgery.On (b)(6) 2016, his condition improved and was discharged from the hospital.The hospitalization had been prolonged due to the event.The patient was not re-hospitalized for the event.As of (b)(6) 2016, he recovered from the peritonitis.Corrective treatment: irrigation and relaparotomy.Outcome: recovered.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).No product lot number was provided by the reporter; therefore genzyme biosurgery quality assurance was unable to perform a specific lot history review/investigation in response to this event.All seprafilm lots manufactured by genzyme were released for shipment by quality assurance only after successful completion of quality control certificate of analysis testing and review of all device history records and associated manufacturing process documentation.This lot release procedure provides assurance that all product lots are manufactured under specified process parameters and pass final product specifications.Seprafilm adhesion barrier is packaged in a tyvek holder within a plastic sleeve and sealed in an outer foil pouch.The contents of the foil pouch are sterilized by gamma radiation.Product safety metrics are compiled by genzyme/sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal would be discussed during these trending meetings and escalated to the safety governance for adjudication.If a lot number for this event is reported at a later date, this product event will be reopened and an investigation will be performed by genzyme-sanofi biosurgery quality assurance at that time.Diagnosis: abdominal pain (abdominal pain).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: pyrexia (pyrexia).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: crp increased to 20 mg/dl (crp increased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: platelets decreased (platelets decreased).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.Diagnosis: peritonitis (peritonitis).Reporting surgeon's seriousness assessment: serious (hospitalization or prolongation of hospitalization).Reporting surgeon's causality assessment: unknown.The attending physician's comment: the patient was suspected to have hypersensitivity to a component of seprafilm.The alternative explanation for the peritonitis was the patient's risk factor (unspecified) or unknown.Inflammation findings were aggravated and the patient had symptoms of peritonitis after the surgery.Liquid substance which was considered to be gelled seprafilm was noted during the investigational laparotomy, and the findings improved with removal of the liquid substance and adequate irrigation.In addition, cloudy serous ascites was also observed, and was suspected to be a possible complication of seprafilm.Additional information was received on 21-sep-2016 from a physician (surgeon).The medical history and concomitantly used medical devices were added.The verbatim for the symptom of crp increased was updated to crp increased to 20 mg/dl.The lot numbers of seprafilm were added.The onset date for abdominal pain and pyrexia was updated from (b)(6) 2016.The outcome for abdominal pain, pyrexia, crp increased to 20 mg/dl, and platelets decreased was provided as recovering as of (b)(6) 2016.The reporter's seriousness assessment of hospitalization and the causality assessment for abdominal pain, pyrexia, crp increased to 20 mg/dl and platelets decreased were added and the case was upgraded to serious.Clinical course updated and text amended accordingly.Additional information was received on 06-oct-2016.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 12-oct-2016 from pharmacist via health authority ((b)(4)).Product indication was added.Event verbatim was updated from inflammation to localised inflammation of the intraperitoneal area.Hospital discharge date for all the events was added.Laboratory investigations were added.Clinical course was updated and text was amended accordingly.Additional information was received on 24-oct-2016 from the surgeon.The medical history and concomitant medication were added.The event of localised inflammation of the intraperitoneal area was updated to peritonitis and the events of abdominal pain and platelets decreased were updated as the symptoms of this event.The symptom of wbc increased was added for the event of peritonitis.The dose of seprafilm was updated.The relevant lab data and examination finding were added.The detailed description of the surgery was added.The outcome for the event of peritonitis was updated from recovering to recovered and the date the patient recovered was added.The reporter's comment was updated.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 24-oct-2016: this case concerns a male patient who underwent small intestinal resection for adhesive ileus and sheet of seprafilm was applied to this site and later on hospitalized for peritonitis.However, patient's medical history, underlying condition and advancing age are confounding factors for the event.Also, the information regarding patient's concurrent conditions, concomitant medications or other risk factor will aid in complete assessment of this case.
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