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 Hemorrhage/Bleeding (1888); Laceration(s) (1946); Sepsis (2067); Insufficient Information (4580)

Event Date 07/01/2023

Event Type  Injury  

Event Description

Title : comparing the effect of monofilament and braided suture on pregnancy loss rates in women requiring vaginal cervical cerclage the research aims to assess the efficacy of monofilament versus braided sutures in preventing miscarriage for women undergoing vaginal cervical cerclage.Between january 2020 to november 2022, a total of 201 participants were included in the trial.Females with a singleton pregnancy and a cervical cerclage indicator were split evenly amongst receiving a monofilament or braided suture.When possible, braided sutures should be made from mersilene [a non-absorbable suture made of polyethylene terephthalate], and monofilament sutures should be made from ethilon [ethicon], a non-absorbable suture made of long-chain aliphatic polymers of nylon.The reported complications included maternal sepsis (n=11), preterm prelabour membrane rupture (n=40),cervical laceration (n=2), bleeding from cervix (n=5), difficulty in removal (n=46), and need for anesthetic (n=73).In conclusion, both monofilament and braided sutures are effective and safe procedures with minimal side effects and complications.Although monofilament suture may cause more difficult removal and removal complications, it remains a viable option for treating cervical insufficiency.

Manufacturer Narrative

Product complaint # (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.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 2210968-2024-02785 and 2210968-2024-02786 citations : international journal of medical arts.Vol 5 (7).3404-3411.Https://doi.Org/10.21608/ijma.2023.212954.1693.

• 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: 18873422
• MDR Text Key: 337299469
• Report Number: 2210968-2024-02786
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: NA
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 02/14/2024
• 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