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

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

Patient Problems Unspecified Infection (1930); Hernia (2240)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Title: prevention and management of post-deep inferior epigastric perforator flap abdominal bulge: a 5-year single-surgeon series.The aim of the study was to review the impact of permanent subrectus mesh placement on the incidence of post - diep bulge.All patients who underwent unilateral or bilateral diep breast reconstruction by the senior author between 2015 and 2020 were included in the study.A total of 276 patients were included in the study with 142 in the permanent mesh (pm) group and 134 patients in the non permanent mesh (npm) group.The latter comprised 94 patients who underwent semi-permanent subrectus mesh placement and 40 patients with no mesh.Vypro mesh (ethicon) was used to patients who underwent semi-permanent subrectus mesh placement; 3/0 monocryl suture (ethicon) was used in the rectus muscle fibers at the site of the dissection; 0/0 loop ethilon suture (ethicon) was plicated in a cranio-caudal direction; 2/0 pds (ethicon) was used during the placement of drains and closure of the abdomen and prineo tape (ethicon) was applied in the wound.Reported complications are abdominal bulging/hernia, infection and abdominal weakness.In conclusion, the study demonstrates that a low rate of abdominal morbidity can be achieved with the placement of a permanent subrectus mesh.

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.Citation: journal of plastic, reconstructive & aesthetic surgery 75 (2022) 3683-3689/ https://doi.Org/10.1016/j.Bjps.2022.06.017.Related events captured via 2210968-2023-09592, 2210968-2023-09594, 2210968-2023-09595, 2210968-2023-09596.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, 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: 18287972
• MDR Text Key: 329995001
• Report Number: 2210968-2023-09593
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K946173
• 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

• Date FDA Received: 12/07/2023
• 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: 11/27/2023
• 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