MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported in a literature article (title: mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation) that patient underwent laparoscopic ventral hernia repair between april 2005 and january 2008 and suture was used.The primary outcome parameter of this study was mesh shrinkage; secondary outcome parameters included postoperative pain and surgical complications.For suture fixation nonabsorbable monofilament sutures were placed alternatively at 2-3cm intervals along the mesh margin.It is possible that the patient experienced recurrent hernia, nerve irritation, or post operative pain.It was reported that pain after mesh fixation with transfascial sutures is likely due to nerve irritation or entrapment and the relatively small distance between individual sutures used in the study.There was a significant reduction of pain between 6 weeks and 6 months postoperation which could be in response to desensitization of entrapped nerve fibers or in response to resolution of local inflammation.Treatment of the event was not reported.Additional information will be requested.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7101193
• MDR Text Key: 94291462
• Report Number: 2210968-2017-71690
• 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,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention