| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Foreign Body Reaction (1868); Pain (1994); Hernia (2240)
|
| Event Date 04/28/2019 |
|
Event Type
Injury
|
|
Event Description
|
|
Right inguinal hernia sac abscess [groin abscess] ([abscess discharge], [pyrexia], [groin pain]).Case narrative: initial information received on 22-jan-2020 regarding an unsolicited valid serious case issued from a literature article.Title: 27: a case of asynchronously onset inguinal hernia sac abscess following an emergency surgery for mesenteric hiatal hernia authors: yamashi k, fumino s, kambe k, nagano s, nagayabu k, sakai k, et al.Journal: journal of the japanese society of pediatric surgeons/the 55th kinki regional meeting of the japanese society of pediatric surgeons.2019;55:1213.This case involves a (b)(6) years old male patient who experienced right inguinal hernia sac abscess, while he was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing mechanical ileus, incarcerated hiatus hernia and hydrocele.Concomitant medications included aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin (bolheal) for small intestine operation.On an unknown date, the patient visited the previous physician for lower abdominal pain, diagnosed with strangulated intestinal obstruction on contrast-enhanced ct, and was emergently transported to the reporting hospital.On an unknown date, the patient underwent an emergency surgery, and diagnoses of incarcerated hiatus hernia in the mesentery proper and right peritoneal patent processus vaginalis were made based on laparoscopic observation.The incarceration was released with a laparotomy, and after sutural closure of the mesenteric defect hole, the suture was reinforced with neoveil and bolheal.Carboxymethylcellulose, sodium hyaluronate was placed, and the surgery was completed.On an unknown date (postoperative day 8), the course was favorable and the patient was discharged from the hospital.On an unknown date (postoperative day 10), pyrexia and right groin pain developed.On an unknown date, the patient visited the reporting hospital.An ultrasound and a contrast-enhanced ct showed suspected right incarcerated inguinal hernia of the greater omentum, and an emergency surgery was performed.A laparoscopy showed purulent coating attached to the internal inguinal ring, and a diagnosis of right inguinal hernia sac abscess was made with inguinal approach.(treatment: total resection of the hernia sac.) on pathologic examination, the patient was diagnosed as having abscess due to some kind of foreign body.As of an unknown date, outcomes of purulent coating attached to the internal inguinal ring, right inguinal hernia sac abscess, right groin pain, and pyrexia were unknown.The patient developed an event of a serious right inguinal hernia sac abscess (groin abscess).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious purulent coating attached to the internal inguinal ring.This event was assessed as medically significant and leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious right groin pain (groin pain).This event was assessed as medically significant and leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious pyrexia.This event was assessed as medically significant and leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: computerised tomogram - on an unknown date: [suspected right incarcerated inguinal hernia of the greater omentum].Laparoscopy - on an unknown date: [purulent coating attached to the internal inguinal ring was noted, and inguinal approach showed right inguinal hernia sac abscess.] ultrasound scan - on an unknown date: [suspected right incarcerated inguinal hernia of the greater omentum].Final diagnosis was right inguinal hernia sac abscess.An unknown corrective treatment was received.The patient outcome is reported as unknown for right inguinal hernia sac abscess, as unknown for right groin pain, as unknown for purulent coating attached to the internal inguinal ring and as unknown for pyrexia.Reporter comment: with regard to "right inguinal hernia sac abscess", in this case, it was possible that a surgical material from the first surgery got into the patent's internal inguinal ring and caused the asynchronous infection, which should be considered as one of the causative factors for the postoperative inguinal hernia sac abscess.
|
| |
|
Event Description
|
|
Right inguinal hernia sac abscess [groin abscess] ([abscess discharge], [pyrexia], [groin pain]).Case narrative: initial information received on 22-jan-2020 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference on 10-feb-2020 and transmitted to sanofi.[literature information] title: 27: a case of asynchronously onset inguinal hernia sac abscess following an emergency surgery for mesenteric hiatal hernia authors: yamashi k, fumino s, kambe k, nagano s, nagayabu k, sakai k, et al.Journal: journal of the japanese society of pediatric surgeons/the 55th kinki regional meeting of the japanese society of pediatric surgeons.2019;55:1213.This case involves a 10 years old male patient who experienced right inguinal hernia sac abscess, while he was treated with with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing mechanical ileus, incarcerated hiatus hernia and hydrocele.Concomitant medications included aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin (bolheal) for small intestine operation.On an unknown date, the patient visited the previous physician for lower abdominal pain, diagnosed with strangulated intestinal obstruction on contrast-enhanced ct, and was emergently transported to the reporting hospital.On an unknown date, the patient underwent an emergency surgery, and diagnoses of incarcerated hiatus hernia in the mesentery proper and right peritoneal patent processus vaginalis were made based on laparoscopic observation.The incarceration was released with a laparotomy, and after sutural closure of the mesenteric defect hole, the suture was reinforced with neoveil and bolheal.Carboxymethylcellulose, sodium hyaluronate was placed, and the surgery was completed.On an unknown date (postoperative day 8), the course was favorable and the patient was discharged from the hospital.On an unknown date (postoperative day 10), pyrexia and right groin pain developed.On an unknown date, the patient visited the reporting hospital.An ultrasound and a contrast-enhanced ct showed suspected right incarcerated inguinal hernia of the greater omentum, and an emergency surgery was performed.A laparoscopy showed purulent coating attached to the internal inguinal ring, and a diagnosis of right inguinal hernia sac abscess was made with inguinal approach.(treatment: total resection of the hernia sac.) on pathologic examination, the patient was diagnosed as having abscess due to some kind of foreign body.As of an unknown date, outcomes of purulent coating attached to the internal inguinal ring, right inguinal hernia sac abscess, right groin pain, and pyrexia were unknown.The patient developed an event of a serious right inguinal hernia sac abscess (groin abscess).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious purulent coating attached to the internal inguinal ring (abscess).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious right groin pain (groin pain).This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious pyrexia.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: computerised tomogram - on an unknown date: [suspected right incarcerated inguinal hernia of the greater omentum].Laparoscopy - on an unknown date: [purulent coating attached to the internal inguinal ring was noted, and inguinal approach showed right inguinal hernia sac abscess] ultrasound scan - on an unknown date: [suspected right incarcerated inguinal hernia of the greater omentum].Final diagnosis was right inguinal hernia sac abscess.An unknown corrective treatment was received.The patient outcome is reported as unknown for right inguinal hernia sac abscess, as unknown for right groin pain, as unknown for purulent coating attached to the internal inguinal ring and as unknown for pyrexia.Reporter comment: with regard to "right inguinal hernia sac abscess", in this case, it was possible that a surgical material from the first surgery got into the patent's internal inguinal ring and caused the asynchronous infection, which should be considered as one of the causative factors for the postoperative inguinal hernia sac abscess.Additional information was received on 10-feb-2020 from the physician: reference ids (mft.Rpt.# and partner number) were added.No other new information was received.
|
| |
|
Event Description
|
|
Right inguinal hernia sac abscess [groin abscess] ([abscess discharge], [pyrexia], [groin pain]).Case narrative: initial information received on 22-jan-2020 regarding an unsolicited valid serious case received from (lp) japan-kaken lsa-pcp under reference (b)(4) on 25-feb-2020 and transmitted to sanofi.[literature information]: title: 27: a case of asynchronously onset inguinal hernia sac abscess following an emergency surgery for mesenteric hiatal hernia authors: yamashi k, fumino s, kambe k, nagano s, nagayabu k, sakai k, et al.Journal: journal of the japanese society of pediatric surgeons/the 55th kinki regional meeting of the japanese society of pediatric surgeons.2019;55:1213.This case involves a 10 years old male patient (131 cm and 25 kg) who experienced right inguinal hernia sac abscess, while he was treated with aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin [bolheal] and with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included mechanical ileus, incarcerated hiatus hernia on 18-apr-2019, inguinal hernia in oct-2009, inguinal hernia repair in oct-2009, intestinal operation on 18-apr-2019 and hydrocele on 18-apr-2019.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing dermatitis atopic and inguinal hernia since 30-apr-2019, and was non-tobacco user.Notes: outpatient.It was unknown if mechanical ileus, incarcerated hiatus hernia, and hydrocele were coexisting or past history.Concurrent condition before surgery: none.Diabetes mellitus: none.Concomitant medications included paracetamol (acelio) for postoperative analgesia; famotidine (famotidine) for prophylaxis against gastrointestinal ulcer; fentanyl citrate (fentanyl [fentanyl citrate]) for postoperative analgesia; cefmetazole sodium (cefmetazole sodium) for infection prophylaxis and post procedural infection; and clostridium butyricum (miya bm) for gastrointestinal disorder.On an unknown date, the patient visited the previous physician for lower abdominal pain, was diagnosed with strangulated intestinal obstruction on contrast-enhanced ct, and was emergently transported to the reporting hospital.Before surgery: underlying disease (disease that was the reason for the surgery): hiatal hernia of the intestinal mesentery patient's condition: preoperative condition: generally healthy with good nutrition, anemia: none, radiotherapy: none.On 18-apr-2019, emergency surgery was decided, and hiatal hernia incarceration of the small intestinal mesentery and patency of the right vaginal process of the peritoneum were diagnosed by laparoscopic observation.The incarceration was released by laparotomy.After radical operation (the hiatus was sutured without intestinal resection) and suture of the mesentery defect, reinforcement with neoveil and bolheal was performed.Seprafilm (one sheet, lot number: unknown) was placed for adhesion prevention, and the surgery was completed.During surgery: date of surgery and operative method: date of admission: 18-apr-2019, date of surgery (date of the use of seprafilm): 18-apr-2019 (not elective surgery), operative method/reconstruction method: release of the intestinal obstruction and closure of the mesenteric hiatus, hyperthermic treatment during surgery: none, date of discharge: 26-apr-2019.Use of seprafilm: placing site: immediately below the wound and in the abdominal cavity, infection at the placing site: none, direct placing to the anastomosis site: none, wrapping on the suture line of anastomosis part of intestinal tract: none, the placing condition: good, number of the sheet: one sheet, the surgeon's use experience of seprafilm: presence.Condition of the surgery: site of placement of drain: none existing adhesion: none, exfoliation: none.Intra-abdominal cavity: existing non-purulent inflammation: presence, existing infection: none, interperitoneal lavage: presence anastomosis of the resected parts: excision site: none, surgical field condition: clean surgery.Suture of abdominal incision: length of abdominal incision: about 4 cm, suture layer: 2 layers, suture method of the first layer (peritoneum layer): knotted suture, suture thread: absorbable, synthetic, multi, name (2-0 ploysorb), suture method of the skin layer: manually sutured (knotted suture), suture thread: absorbable, synthetic, mono, name (5-0maxon), existing non-purulent inflammation: none, existing infection: none.Surgery: surgery time: about 2 hours, amount of bleeding: 16 g, blood transfusion: none after surgery: concomitant use of other medical devices: none.On 22-apr-2019, the patient started drinking water.On 26-apr-2019, the patient started eating foods.The course was favorable, and the patient was discharged from the hospital on postoperative day (pod) 8.On 28-apr-2019, on pod 10, pyrexia and right groin pain occurred.Abscess in the right inguinal hernial sac developed.On 30-apr-2019, the patient visited the emergency department for right groin pain.Incarcerated right inguinal hernia of the greater omentum was suspected by ultrasound examination and contrast enhanced ct, and right inguinal hernia was diagnosed.Surgery on the following day was decided.On 01-may-2019, laparoscopically assisted radical operation for the right inguinal hernia was performed.The findings during surgery showed abscess formation in the right inguinal area.Laparoscopy showed pus at the internal inguinal ring, and abscess in the right inguinal hernial sac was diagnosed by inguinal approach.Later, pathological diagnosis of abscess due to some foreign substance was made (treatment: total resection of the hernial sac and the administration of cefmetazole at 1 g every 12 hours (from 01-may-2019 to 05-may-2019).Method of confirmation of the adverse events: ct.Treatment for the adverse events: re-hospitalization for treatment: presence: date of re-admission: 30-apr-2019, date of discharge: 06-may-2019.Re-laparotomy: presence, date of re-laparotomy: 01-may-2019.Status at re-laparotomy: in the right inguinal hernia.Condition of seprafilm: it had completely been absorbed into the body.Removal of seprafilm: removed (method: surgery).Other measures: none.After re-laparotomy, the adverse events markedly improved.On 02-may-2019, the patient started eating foods.On 06-may-2019, the patient was discharged from the hospital.On 11-feb-2020, the pyrexia, pus at the internal inguinal ring, abscess in the right inguinal hernial sac, and right groin pain resolved.The patient developed a serious right inguinal hernia sac abscess (groin abscess) 10 days following the first dose intake and 9 days following the last dose intake of aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized 2 days after this event occurred.The patient was discharged on 06-may-2019 (hospitalization during 6 days).The patient developed a serious purulent coating attached to the internal inguinal ring (abscess) 14 days following the first dose intake and 13 days following the last dose intake of aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin.This event was assessed as medically significant and was leading to intervention.The patient was already hospitalized when the event occurred.The patient was discharged on 06-may-2019 (hospitalization during 6 days).The patient developed a serious right groin pain (groin pain) 10 days following the first dose intake and 9 days following the last dose intake of aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized 2 days after this event occurred.The patient was discharged on 06-may-2019 (hospitalization during 6 days).The patient developed a serious pyrexia 10 days following the first dose intake and 9 days following the last dose intake of aprotinin,calcium chloride,factor i (fibrinogen),factor xiii (fibrin stabilising factor),thrombin.This event was assessed as medically significant and was leading to intervention.The patient was hospitalized 2 days after this event occurred.The patient was discharged on 06-may-2019 (hospitalization during 6 days).Relevant laboratory test results included: bacterial test - on 01-may-2019: [tested bacterial strain: aerobic bacteria in general, anaerobic bacteria in general, isolated bacteria: present (isolated bacterium: mssa [methicillin-resistant staphylococcus aureus])].C-reactive protein - on 30-apr-2019: 1.08 [1.08].Computerised tomogram abdomen - on 30-apr-2019: [incarcerated right inguinal hernia of omentum suspected].Histology - on 01-may-2019: [diagnosis of abscess due to foreign body of some sort (foreign body reaction)].Laparoscopy - on 01-may-2019: [pus in internal inguinal ring, abscess in right inguinal hernia sac with inguinal approach].Lymphocyte percentage - on 30-apr-2019: 18.6 %.Neutrophil percentage - on 30-apr-2019: 70.8 %.Ultrasound scan - on 30-apr-2019: [incarcerated right inguinal hernia of omentum suspected].White blood cell count - on 30-apr-2019: 15900 [15900] final diagnosis was mild right inguinal hernia sac abscess.An unknown corrective treatment was received.The patient outcome is reported as recovered / resolved on 11-feb-2020 for right inguinal hernia sac abscess, as recovered / resolved on 11-feb-2020 for right groin pain, as recovered / resolved on 11-feb-2020 for purulent coating attached to the internal inguinal ring and as recovered / resolved on 11-feb-2020 for pyrexia.Reporter comment: with regard to "right inguinal hernia sac abscess", in this case, it was possible that a surgical material from the first surgery got into the patent's internal inguinal ring and caused the asynchronous infection, which should be considered as one of the causative factors for the postoperative inguinal hernia sac abscess.Allergy disposition related to the adverse events: dermatitis atopic causal relationship of the pyrexia, pus at the internal inguinal ring, abscess in the right inguinal hernial sac, and right groin pain to seprafilm: the foreign substances used at the first surgery included neoveil, bolheal, and seprafilm.The substance that wandered off into the hernial sac and caused the infection was unknown.Causal relationship of the pyrexia, pus at the internal inguinal ring, abscess in the right inguinal hernial sac, and right groin pain to seprafilm: probable other factors suspected as the cause of the adverse events: surgical invasion, the concomitant drugs, concomitant medical devices (including suture thread and drain); suspected factors (neoveil, bolheal).Additional information was received on 10-feb-2020 from the physician: reference ids (mft.Rpt.# and partner number) were added.No other new information was received.Additional information was received on 25-feb-2020 from the physician: added patient information, other relevant history, and laboratory data; updated lot number and indication for use of seprafilm; updated information on bolheal (changed from a concomitant drug to a suspect drug and updated dosage regimen and product details); added concomitant drugs; updated event information; and updated clinical course and reporter comment.Local comments: *downgrade*.
|
| |
|
Search Alerts/Recalls
|
|
