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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Title: comparative study of staplers vs simple interrupted vs sub-cuticular method of skin closure of surgical wounds.The objective of this study is to compare staplers vs simple interrupted vs sub-cuticular method of skin closure of surgical wounds.The present randomized prospective study was conducted in the department of surgery at rohilkhand medical college and hospital, bareilly from january 2020 to october 2021 among 150 subjects who underwent surgical procedures.Equal number of patients was allotted to 3 groups by random envelope allocation method i.E.Group a(stapled skin closure), group b(interrupted skin closure) and group c(sub cuticular skin closure).Following the completion of closure, an antiseptic medicated cream was applied followed with a protective dressing for the first 24¿72 h.Synthetic non-absorbable monofilament (ethilon) nylon skin stapler (ethicon proximate) were used.Reported complications included interrupted skin closure postoperative pain score at 6 hours (3.58 -1.032), stapled skin closure (3.20 - 1.015), interrupted skin closure postoperative pain score at 48 hours (1.88 -.895), stapled skin closure (1.78 -.616), wound infection.In conclusion in this we found that time required for skin closure (in seconds) was least in stapled skin closure group while pain and posas score was minimum in sub-cuticular skin closure group.Wound infection was present maximum and minimum among sub-cuticular and interrupted skin closure group respectively.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation cite: european journal of molecular & clinical medicine issn 2515-8260 volume 09, issue 03, 2022.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15432379
• MDR Text Key: 300037286
• Report Number: 2210968-2022-07612
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 09/07/2022
• 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