MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

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

Patient Problems Fever (1858); Inflammation (1932)

Event Date 08/25/2023

Event Type  Injury  

Event Description

Title: barbed sutures and their potential role in reducing inflammatory reaction after cesarean delivery: a single-center experience.The aim of this retrospective cohort study was to investigate the short-term outcomes of knotless barbed sutures used for both closures of myometrium and subcuticular tissues in patients with various operative indications and who underwent cesarean delivery (cd) in a single tertiary center.A case-control study was conducted at the osaka city university graduate school of medicine, osaka, japan.The patients were divided into two groups.The barbed suture group consisted of patients (n=221) who underwent cd using a barbed suture for uterine closure (0 stratafix® spiral pds plus) and subcuticular closure (4-0 stratafix® spiral pds plus) between december 2019 and december 2020.The non-barbed group consisted of patients (n=211) who underwent cd using a monofilament suture for uterine closure (0-monocryl®, ethicon, somerville, nj, usa) and subcuticular closure (3-0 opepolyx®, alfresa, tokyo, japan) between october 2018 and october 2019.When additional sutures were required for sufficient hemostasis of the uterine incision, 0 pds plus (ethicon) was used in a figure-of-eight suture for both groups.Hyaluronic acid/carboxymethylcellulose (seprafilm®, baxter, deerfield, il, usa) was placed on the uterine closure site to prevent post-operative adhesion in cases with intact membranes [7].Reported complications include fever >38°c due to endometritis (n=3) in the barbed group and (n=4) in the non-barbed group.In conclusion, barbed sutures can be used without major complications in patients who have undergone cd, including high-risk pregnancies.

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.An attempt has been 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via: 2210968-2024-02766 and 2210968-2024-02767.Citation: cureus 2023;15(8): e44094.Doi 10.7759/cureus.44094; https://www.Cureus.Com/articles/146400-barbed-sutures-and-their-potential-role-in-reducing-inflammatory-reaction-after-cesarean-delivery-a-single-center-experience#!/.

• Brand Name: MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 18869189
• MDR Text Key: 337290649
• Report Number: 2210968-2024-02765
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/08/2024
• 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
• Patient Sex: Female