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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

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 the monocryl or nylon suture caused and/or contributed to the adverse events described in the article, specifically: infection? if yes, provide details of event and specific product codes of suture used.Were cultures taken and what were the results? citation: surg neurol int.2012;3:94.Doi: 10.4103/2152-7806.99941.(b)(4).

Event Description

It was reported in journal article ¿title: skin closure in vascular neurosurgery: a prospective study on absorbable intradermal suture versus non-absorbable suture¿ that patient underwent craniotomy and suture was used continuously to close the scalp.A prospective study was carried out between january 2009 and october 2010.The patient possibly developed wound infection with good response with the use of oral antibiotic.In conclusion, the closure with intradermal suture alone in craniotomies is as safe as the traditional skin closure with nylon sutures, besides eliminating the need for suture removal and providing a cosmetic advantage.Additional information has been 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 (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7186688
• MDR Text Key: 97119947
• Report Number: 2210968-2018-70253
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/26/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/12/2018
• 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