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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Scarring (2061); Post Operative Wound Infection (2446)

Event Date 05/03/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that vicryl plus and ethilon sutures caused and/or contributed to the adverse events described in the article, specifically: wound infection, scarring and antibiotics treatment if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date and type of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for vicryl plus and ethilon? citation: world j surg (2012) 36:2230¿2236; doi 10.1007/s00268-012-1639-4.

Event Description

It was reported in a journal article that the patient underwent innervated perforator flap procedure on an unknown date between 9/2005 and 4/2010 and suture was used.In order to preclude any dead space formation and optimal distribution of tension, wound closure was achieved by three layers of sutures: once the flap had been adequately fixed by the deep absorbable sutures, complete wound closure was achieved by placement of subcutaneous absorbable and tension-free non-absorbable monofilament back-stitch skin sutures.The patient was instructed to refrain from sedentary positioning as possible until final removal of the sutures on postoperative day 14.It was possible that the patient developed superficial wound infection, which responded well to selective oral antibiotics and local care.It is also possible that the patient developed scarring.The patient was able to return to normal routine with no limitations.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7035320
• MDR Text Key: 92153705
• Report Number: 2210968-2017-71258
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention