MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abnormal Vaginal Discharge (2123); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: br.J.Surg.1988, vol.75, october, 101-2-1-01-5.(b)(4).

Event Description

It was reported via journal article: title: "abdominoperineal and anterior resection of the rectum with retrocolic omentoplasty and no drainage." author(s): s.R.G.Smith, i.Swift, h.Gompertt and w.N.W.Baker.Citation: br.J.Surg.1988, vol.75, october, 101-2-1-01-5.This study aimed to describe the experience of using the omentum for low colorectal anastomoses and primary perineal wound closure after abdominoperineal excision of the rectum.Since 01mar1986, 40 patients (n=19 male and n=21 female; mean age of 65±10.9 years) underwent anterior resection (n=26), abdominoperineal resection (n=11) and extended hartmann's operation (n=3), with retrocolic omentoplasty.All anastomoses in retrocolic omentoplasty were constructed using one layer of interrupted 2/0 nurolon sutures.In patients under anterior resection group, one patient developed anastomotic leakage with abdominal pain and fever for 24h settled on treatment with clear fluids "ad" antibiotics; gastrografin enema confirmed the presence of a leak and ultrasound showed small retrorectal collection, and later developed soft anastomotic stricture which was easily dilated digitally.Another 2 patients developed urinary tract infection with delayed rise in temperature which appropriately responded to treatment.Additionally, 3 patients demonstrated radiological leak for which 2 were asymptomatic and one was a (b)(6) female patient with vaginal discharge lasted in 4 days.Furthermore, 3 additional patients developed anastomotic strictures, one in (b)(6) female patient treated with dilatation of sigmoidoscope at 6 weeks, and the other two required dilatation under general anesthetic twice and three times, respectively after resections for diverticular disease and carcinoma."rectocolic" omentoplasty is a simple, safe and effective adjunct to rectal surgery.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8091549
• MDR Text Key: 127959521
• Report Number: 2210968-2018-77262
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR