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

Catalog Number 698G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Irritation (1941); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional contact office information: (b)(4).Additional information: the actual device batch number associated with this event is not known.Seven possible batch numbers are reported: batch# kcj661, exp.Date 02/26/2021, mfr.Date 03/29/2016.Batch# kdb852, exp.Date 03/31/2021, mfr.Date 04/02/2016.Batch# kgp692, exp.Date 05/31/2021, mfr.Date 06/07/2016.Batch# kdp804, exp.Date 03/31/2021, mfr.Date 04/11/2016.Batch# kgq061, exp.Date 05/31/2021, mfr.Date 06/25/2016.Batch# khh231, exp.Date 06/30/2021, mfr.Date 07/16/2016.Batch# khj064, exp.Date 06/30/2021, mfr.Date 07/27/2016.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.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.Additional information was requested and the following was obtained: below is a brief summary of our discussion with dr.: dr.Recapped each of 5 cases he encountered recently with reaction to 5-0 ethilon nylon suture as stated in his letter to us.Through inquiry, it was confirmed that the sutures were used for skin closure.He agreed and believed that the current reaction issue might be associated with the specific lot.He said that the alleged suture were likely from same lot.Our sales rep had some unused sutures from the same lot.He did save one piece of removed suture.Letter from surgeon attached: i am in receipt of your questions regarding my patients that had allergic type reactions to your 5-0 nylon sutures.As far as your questions are concerned over a three-week period suddenly i had five patients with allergic reactions to the 5-0 nylon sutures.Three had very bright red irritated tissue around the suture itself in the wounds.Two had an extreme pruritus over the suture area in the recovery room.One, we were able to give decadron.The other i had to remove the sutures in the recovery room because of the extreme uncomfortable pruritus, replace the 5-0 nylon with 5-0 prolene made by you.This resolved the problem.Therefore, there was no question these sutures were causing an irritation and allergic type reaction in these patients.They were from multiple backgrounds.There was no notable increased bmi or history of allergies to medications in these patients.There was no question visually that the sutures themselves, the 5-0 nylon, causing the problem.The symptoms resolved once the sutures were removed.

Event Description

It was reported that the patient underwent a hand surgical procedure on unknown date and the suture was used.Following the procedure, the patient developed very bright red irritated tissue around the suture itself in the wound.The surgeon opined that there was no question the suture was causing an irritation and allergic type reaction in the patient.There was no notable increased bmi or history of allergies to medications in the patient.The symptoms resolved once the suture was removed.

• Brand Name: ETHILON NYLON SUTURE
• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; 9082182792
• MDR Report Key: 6265367
• MDR Text Key: 65344953
• Report Number: 2210968-2017-30306
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 698G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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