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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 vicryl rapide caused and/or contributed to the adverse events described in the article? can specific patient demographics be provided for the subjects of this article? if so, please also include: patient initials, initial procedure date, pre-existing conditions, specific medical/surgical intervention per patient.Is the product code and lot number available for any of the ethicon devices used? citation: int j colorectal dis (2010) 25:395¿400.Doi 10.1007/s00384-009-0804-1.

Event Description

It was reported in a journal article that a patient underwent primary closure of pilonidal sinus on unknown date and suture was used for skin closure.This study compared excision and primary closure of pilonidal sinus using incorporated gentamicin impregnated collagen with conventional laying open.A study of chronic pilonidal sinus patients with procedures performed between 06/1999 and 12/2000.Pain scores were reviewed on day 1, 2, 4, 7 and 14 post op.Patients in the closed group experienced significantly less pain on days 2, 4 and 7.The patient possibly experienced pain treated with oral analgesics.Additional information has been requested.

Manufacturer Narrative

Product complaint #
=
> pc-000074147 additional information was requested and the following was obtained: in the paper we have simply quoted the materials that were used in comparing what was at that time two relatively standard techniques neither of which had ever resulted in a 100% cure rate.In answer to your specific questions:- the cases were not reported to ethicon we do not believe that any specific suture material contributed to wound failure patient demographics cannot be provided specific lot numbers cannot be provided.

• 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: 7119030
• MDR Text Key: 94931278
• Report Number: 2210968-2017-71800
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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?: No
• Date Manufacturer Received: 01/29/2018
• 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