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); Irritation (1941); Itching Sensation (1943); Reaction (2414); No Code Available (3191)

Event Date 11/07/2016

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.Additional information was requested and the following was obtained: lot# - unknown.Please clarify surgery /procedure name and what is the wound related to - multiple surgeries.What is tissue type and location of the suture placement - subcuticular.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased - normal.What suture/device was used in the initial procedure - ethilon.How was the suture placed (interrupted or continuous) - unknown.How was the suture tied - unknown.Were there any intra-operative complications - unknown.What in the physicians opinion are the factors contributing to the event - possibly patient factors, surgeon has switched to prolene.Any quality issues noted with the suture intra-op/post-op - none that were noticeable.Please provide the wound closure device types, including adhesive bandages and wet/dry wound dressings - unknown.Please clarify, were symptoms noticed post-op/intra-op or during use on patient/during procedure - post-op.What date did the patient present with symptoms (# post op days) - immediately after coming out of anesthesia.Was there any type of surgical or medical intervention required to treat the itching sensation, around the surgical sites - it is mentioned in report that prolene was used to complete the case, please clarify when was prolene used - initial procedure or post-op - benadryl, when itching became uncontrollable the ethilon was removed and prolene was placed.Has the itching sensation subsided as time has gone on - no.What is patient current status - to my knowledge the patient is okay.

Event Description

It was reported that the patient underwent a general open surgical procedure on (b)(6) 2016 and the suture was placed in subcuticular tissue.Following the procedure, immediately after coming out of anesthesia, the patient experienced redness and itching at the suture and benadryl was applied.When itching became uncontrollable, the suture was removed and other suture was placed.Currently, the patient is okay.The doctor opines that patient factors, possibly, were contributing factors.

Manufacturer Narrative

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.According the sample condition and evaluation, no defects were found on representative samples.

Manufacturer Narrative

(b)(4).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.

• 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): UNKNOWN; unknown; x
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6221532
• MDR Text Key: 63833918
• Report Number: 2210968-2017-30044
• 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,Followup,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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