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Abscess under the stoma opening section (application site) [application site abscess] ([white blood cell increased], [neutrophil count increased]).Case narrative: based on additional information received on 03-oct-2019, this case previously considered as non-serious was upgraded to serious.Initial information received on 02-oct-2019 regarding an unsolicited valid serious case received from (b)(4)_other sanofi-(b)(4) group employee under reference (b)(4) on and transmitted to sanofi.This case involves a (b)(6) years old female patient (154 cm and (b)(6) kg) who experienced abscess under the stoma opening section (application site), while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included cholelithiasis, uterine prolapse, tendon rupture, anaphylactic reaction, surgery, hysterectomy and colostomy.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 hypertension, atrial fibrillation, food allergy, food allergy and was non-tobacco user.Notes: inpatient.Concurrent condition: hypertension, atrial fibrillation paroxysmal.Historical condition: cholelithiasis, uterine prolapse, left rotator cuff tear.Diabetes mellitus: none.Predisposing factors to allergy: fruit allergy, allergy to soybean milk and others, history of anaphylaxis: 3 times.History of surgery: surgery for cholelithiasis, total hysterectomy, proctectomy (hartmann).Before surgery: underlying disease (surgical indication): status post sigmoid colostomy (status post hartmann's pouch procedure for rectal perforation).Patient's condition: preoperative condition: generally healthy, nutrition status: good, anaemia: none, radiotherapy: none.During surgery: date of surgery and operative procedure) hospitalization start date: (b)(6) 2019, date of surgery (use of seprafilm): (b)(6) 2019 (elective surgery), operative procedure/reconstruction method: laparoscopic artificial anus closure (colon-rectum anastomosis) + intestinal adhesiolysis + partial ileal resection (stoma closure), intraoperative hyperthermic therapy: none, date of discharge: (b)(6) 2019.Application of seprafilm) application site: directly below the umbilicus - artificial anus closure (under the stoma opening section), direct application to the anastomosis site: none, seprafilm directly covering the intestinal anastomosis suture line: no, infection in the application site: none, condition of application: favorable, number of sheets: 4 sheets, operating surgeon's experience in using seprafilm: yes surgical situation) drain placement site: yes, drain type: 24fr j-vac drain (+ transanal mit drain 120 mm).Pre-existing adhesion: yes, site: in pelvis, adhesiolysis: yes.Intraperitoneal) pre-existing non-purulent inflammation: none, pre-existing infection: none, intraperitoneal irrigation: yes (0.1 l).Anastomosis of resection site) resection site: yes (site: stomal colon, damaged small intestine), pre-existing non-purulent inflammation: none, pre-existing infection: none, anastomosis method for the resection site: machine, status of operative field: contaminated: accidental contamination (small intestinal perforation during adhesiolysis).Laparotomy wound suture) length of laparotomy incision: approximately 4 cm, anastomosis method for the first layer (peritoneum): interrupted anastomosis, suture: absorbable (name: 1pds), anastomosis method for the skin: hand suture (purse-string suture leaving the drainage hole in the center), pre-existing non-purulent inflammation: none, pre-existing infection: none.Surgery) operative time: 4 hours, amount of bleeding: 5 g, blood transfusion: none.After surgery: other concomitantly used medical device: yes, drain (placed on (b)(6) 2019, removed on (b)(6) 2019, open drain).Drainage condition: favorable (status when the drainage condition was checked at when the adverse event developed on (b)(6) 2019: drainage was favorable.) on (b)(6) 2019, the patient underwent laparoscopic hartmann's pouch procedure (rectal low anterior resection + transient end sigmoid colostomy) for traumatic rectal perforation due to the use of ichijiku enema.On (b)(6) 2019, the patient was discharged from the hospital as the postoperative course was favorable.On (b)(6) 2019, the patient was hospitalized for stoma closure.On (b)(6) 2019, the patient underwent laparoscopic hartmann reversal (sigmoid colon-rectum anastomosis) + rectal adhesiolysis + partial ileal resection for status post transient end sigmoid colostomy.From (b)(6) 2019, the postoperative course including the rectal anastomosis site was favorable.On (b)(6) 2019, a blood test showed increased white blood cell and neutrophil.A ct scan was performed to search for the cause in addition to the evaluation of failure of the sutures in the rectal anastomosis site, and showed no problem in anastomotic sites in both the rectum and small intestine.On the other hand, there was fluid accumulation with air directly below the abdominal wall of the umbilical stoma closure site, and (intraperitoneal) abscess under the abdominal wall was observed, which was considered to be the increase in inflammation values.Two sutures in the umbilical abdominal rectus muscle were removed, and drainage was performed.Mildly contaminated effusion was drained and submitted for bacterial culture, and a penrose drain was placed.Locations of the onset site and application site (of seprafilm): the onset site seemed obvious to be the application site.On (b)(6) 2019, the drainage of the abscess under the abdominal wall was favorable, and also on a blood test, both white blood cell and neutrophil were tending to improve.The transanal mit drain was removed.On (b)(6) 2019, the rectal anastomosis site drain was removed.On (b)(6) 2019, although the inflammation was tending to improve on a blood test, the discharge from the penrose drain was somewhat purulent, and the patient started taking levofloxacin (lvfx).From (b)(6) 2019, the discharge from the penrose drain was serous and of small amount.On (b)(6) 2019, improvement of inflammation was confirmed on a blood test, and a penrose drain was removed.A ct scan was performed again and showed reduced abscess under the abdominal wall which still slightly remained.On (b)(6) 2019, the patient was discharged from the hospital because no worsening of blood test or clinical symptom was noted.Abscess under the stoma opening section (application site), "neutrophil increased", and "white blood cell increased" were resolving.On (b)(6) 2019, during an outpatient visit, no increase in inflammation values, abdominal pain, or pyrexia suggestive of abscess flare was noted.Examination of adverse event: bacterial culture) specimen name: pus (under the abdominal wall, umbilical stoma closure site), specimen collection date: (b)(6) 2019, types of bacteria to be tested: general anaerobes, bacteria detected: enterococcus faecalis (bacterial load: small), a-streptococcus (bacterial load: small), bacteroides fragilis group 2+.Smear comment: multiple gram-negative rods were noted.The bacterial cell was medium sized and had rounded corners, and was suspected to be enterobacteriaceae such as e.Coli; however, the cells were poorly stained and the possibility of them being anaerobes also could not be ruled out.Laboratory tests regarding infection and inflammation: performed.Treatment for adverse event: prolongation of hospitalization: yes.Re-hospitalization for treatment: none.Re-laparotomy: none.The patient developed an event of a serious abscess under the stoma opening section (application site) (application site abscess).This event was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious white blood cell increased (white blood cell count increased).This event was leading to intervention.The patient was hospitalized for this event.The patient developed an event of a serious white blood cells increased (neutrophil count increased).This event was leading to intervention.The patient was hospitalized for this event.Relevant laboratory test results included: c-reactive protein ( - 0.3 mg/dl) - on (b)(6) 2019: 0.53 mg/dl (borderline); on (b)(6) 2019: 0.19 mg/dl; on (b)(6) 2019: 0.06 mg/dl; on (b)(6) 2019: 8.48 mg/dl (borderline); on (b)(6) 2019: 14.98 mg/dl (borderline); on (b)(6) 2019: 6.96 mg/dl (borderline); on (b)(6) 2019: 5.11 mg/dl (borderline); on (b)(6) 2019: 5.95 mg/dl (borderline); on (b)(6) 2019: 1.95 mg/dl (borderline); on (b)(6) 2019: 1.26 mg/dl (borderline); on (b)(6) 2019: 0.21 mg/dl; on (b)(6) 2019: 0.09 mg/dl; on (b)(6) 2019: 0.08 mg/dl computerised tomogram - on (b)(6) 2019: [there was no problem in anastomotic sites in both the rectum and small intestine.On the other hand, there was fluid accumulation with air directly below the abdominal wall of the umbilical stoma closure site, and (intraperitoneal) abscess under the abdominal wall was observed.]; on (b)(6) 2019: [reduced abscess under the abdominal wall still slightly remained.] eosinophil percentage (0.5 - 11.0 %) - on (b)(6) 2019: 4.1 %; on (b)(6) 2019: 3.5 %; on (b)(6) 2019: 1.1 %; on (b)(6) 2019: 0.1 % [l]; on (b)(6) 2019: 1.5 %; on (b)(6) 2019: 2.7 %; on (b)(6) 2019: 1.9 %; on (b)(6) 2019: 3.0 %; on (b)(6) 2019: 2.2 %; on (b)(6) 2019: 1.8 %; on (b)(6) 2019: 2.4 %; on (b)(6) 2019: 1.6 %; on (b)(6) 2019: 2.4 %.Laboratory test - on (b)(6) 2019: [gnr3+ wbc3+].Neutrophil percentage (37.0 - 73.0 %) - on (b)(6) 2019: 73.7 % (borderline); on (b)(6) 2019: 66.4 %; on (b)(6) 2019: 69.6 %; on (b)(6) 2019: 88.5 % (borderline); on (b)(6) 2019: 87.8 % (borderline); on (b)(6) 2019: 78.5 % (borderline); on (b)(6) 2019: 84.3 % (borderline); on (b)(6) 2019: 77.4 % (borderline); on (b)(6) 2019: 81.5 % (borderline); on (b)(6) 2019: 73.5 % (borderline); on (b)(6) 2019: 62.6 %; on (b)(6) 2019: 73.9 % (borderline); on (b)(6) 2019: 61.2 % white blood cell count (4.0 - 9.0 10*3/ul) - on (b)(6) 2019: 5.6 10*3/ul; on (b)(6) 2019: 4.6 10*3/ul; on (b)(6) 2019: 4.7 10*3/ul; on (b)(6) 2019: 8.6 10*3/ul; on (b)(6) 2019: 9.1 10*3/ul (borderline); on (b)(6) 2019: 6.4 10*3/ul; on (b)(6) 2019: 9.0 10*3/ul; on (b)(6) 2019: 6.1 10*3/ul; on (b)(6) 2019: 5.9 10*3/ul; on (b)(6) 2019: 5.6 10*3/ul; on (b)(6) 2019: 4.2 10*3/ul; on (b)(6) 2019: 4.3 10*3/ul; on (b)(6) 2019: 4.1 10*3/ul.Final diagnosis was mild abscess under the stoma opening section (application site).The patient was treated with levofloxacin hemihydrate (levofloxacin od) for application site abscess.The patient outcome is reported as recovering / resolving for abscess under the stoma opening section (application site), as recovering / resolving for white blood cell increased and as recovering / resolving for white blood cells increased.Reporter comment: causality between abscess under the stoma opening section (application site) and seprafilm: probable the reporter had performed similar artificial anus closure without using seprafilm many times before, but had never experienced formation of abscess under the wall which require drainage.This time, the application site of seprafilm and abscess formation site were in the same location.Therefore, it was considered that a small number of peristomal bacteria was trapped by seprafilm, multiplied, and caused the abscess formation.Additional information was received on 03-oct-2019 from the physician: added patient information, laboratory data, and a treatment drug; updated event information (added onset date and outcome); added associated symptoms; updated clinical course and reporter comment; and added company comment.Additional information was received on 10-oct-2019: changed jp_local partner number in the section of references.Additional information was received on 13-nov-2019 from gqp quality operations, industrial affairs quality information management: investigation summary was received ((b)(4)).Added reporter information and company comment.Correction to the previous report: added seriousness of the event; and added "no" to malfunction in device information.
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