MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	810081L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Urinary Tract Infection (2120)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a history of pelvic static disorders, first operated on with a tot (tension-free vaginal tape) in 2009 due to stress urinary incontinence.Completion of a promonto-fixation via laparoscopy with mesh for prolapse repair, along with the placement of a new suburethral sling via tot on (b)(6) 2023.The patient quickly experienced a new deterioration in urgency leaks, as well as the emergence of urinary infections.On (b)(6) 2024, re-operated to remove the two strips (tot and tvt) via the vaginal route due to erosion.On (b)(6) 2025, partial removal of the promonto-fixation strip placed in 2023 and placement of a urinary sphincter.Additional information has been requested.
Additional 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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Other relevant patient history/concomitant medications? onset date/time of the urgency? please provide the onset date/time of urinary infection.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Please describe any medical intervention performed including medication name and results.When was the mesh exposure first noted by a physician? please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.Were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the relationship between the tvt mesh and event of prolapse? what is the physician¿s opinion as to the etiology of or contributing factors to the reported events? what is the patient's current status? surgeon¿s name? product code and lot number of tvt implanted in 2009? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Additional 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.Additional information: h4, h6.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22287419
• Report Number: 2210968-2025-07083
• Device Sequence Number: 8310137
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: (01)10705031062306(17)240531(10)3944543
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 810081L
• Device Lot Number: 3944543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female