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

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

Patient Problems Unspecified Infection (1930); Scar Tissue (2060)

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.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 ethicon product (nurolon or vicryl suture) involved caused and/or contributed to the post-operative complications described in the article (scar retraction or superficial local infection? does the surgeon believe there was any deficiency with the ethicon product (nurolon or vicryl suture) involved? citation: aesthetic surgery journal.33(4): 545¿560.Doi: 10.1177/1090820x13484493.(b)(4).

Event Description

It was reported via journal article: "title : dynamic definition mini-lipoabdominoplasty combining multilayer liposculpture, fat grafting, and muscular plication" author: alfredo e.Hoyos, md; mauricio e.Perez, md; and luisana castillo, md citation: aesthetic surgery journal.33(4): 545¿560.Doi: 10.1177/1090820x13484493.The authors described a multilayer and 360-degree approach, dynamic definition mini-abdominoplasty (ddm), to create athletic definition and contour and to restore a feminine appearance postpartum.A total of 181 consecutive women (age range: 20 to 56 years old; bmi below 30) underwent ddm between january 2005 and may 2012.Patients who were a minimum of 6 months postpartum and in good health were considered for inclusion in the study.During the surgical procedure, hemostasis was carefully performed in the flap, and the rectus abdominis muscle was plicated by 2-layer stitching consisting of double-x buried stitches with nurolon 0 sutures (ethicon) and vicryl 0 running sutures (ethicon).The flap and the umbilicus were then fixed to the muscular fascia with vicryl 4-0 running sutures (ethicon).Reported complications included scar retraction (n-1) and superficial local infection (n-4) which required antibiotic therapy.Dynamic definition mini-abdominoplasty is a safe and reproducible approach for select women who wish to regain feminine body features after childbirth.It produces better aesthetic results than traditional full abdominoplasty due to minimized scarring and due to muscular plication and fat grafting, which provide definition of the body contour and enhancement of the zones responsible for making women look slimmer and more feminine.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 8020862
• MDR Text Key: 125593820
• Report Number: 2210968-2018-76835
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• 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