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

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Wound Dehiscence (1154); Scarring (2061)

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: pediatr emerg care.2008 mar;24(3):137-42.Doi: 10.1097/pec.0b013e3181666f87 (b)(4).

Event Description

It was reported via journal article title: cosmetic outcomes of absorbable versus nonabsorbable sutures in pediatric facial lacerations author(s): raemma p.Luck, md, mba, robert flood, md, dalit eyal, do, john saludades, md, ciana hayes, bs, and john gaughan, phd citation: pediatr emerg care.2008 mar;24(3):137-42.Doi: 10.1097/pec.0b013e3181666f87 this prospective randomized clinical study aimed to compare the long-term cosmetic outcomes of absorbable versus nonabsorbable sutures for facial lacerations in children and to compare the complication rates and parental satisfaction in the 2 groups.From jun2005 to feb2006, 88 patients (ages 1 to 18 years) with isolated linear facial laceration (1 to 5 cm in length) were initially enrolled and were divided into two groups for skin closures: 5-0 or 6-0 fast absorbing surgical gut (ethicon) and nylon suture (ethicon).A total of 47 patients completed the 3-month evaluation which included 23 patients in catgut group (n=17 male and n=6 female; median age of 64 months [24-218 months old]) and 24 patients in nylon group (n=18 male and n=6 female; median age of 81 months [33-225 months old]).Overall, there were 2 cases of wound dehiscence in catgut group.The second patient was a (b)(6) toddler who had mild dehiscence on day 8 necessitating the application of topical adhesive.On the follow-up visit at 3 months, one patient from nylon group was noted with keloid.The study demonstrates that there are no long-term differences in cosmetic outcomes and complication rates between absorbable catgut sutures and traditional nylon sutures in the repair of facial lacerations in the pediatric population.

• Brand Name: 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: 7710113
• MDR Text Key: 114695048
• Report Number: 2210968-2018-74539
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• 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: 06/27/2018
• 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: 32 MO