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

Catalog Number 810081L

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

Patient Problems Discomfort (2330); Unspecified Kidney or Urinary Problem (4503); Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a procedure on (b)(6) 2014 and suburethral tape was implanted for treatment of long-standing stress urinary incontinence.The patient had been seen more than a year ago for discomfort related to this tape.There is discomfort at the vaginal level as much as possibly on the quality of micturition and the indication of ablation was carried especially on the very high position under the bladder neck of the tape.At the time, the procedure was postponed by the patient and the patient returned one year later.There is a pre-erosive state at the vaginal level with the mucous membrane just on the surface of the tape in its right portion with a very atrophic vagina.The decision was made to remove the tape by vaginal route.Ablation of the tape was performed on (b)(6) 2024.Additional information has been requested.

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.Please provide the patient's demographic information including gender, weight, bmi at the time of index procedure other relevant patient history/concomitant medications? name of index surgical procedure? what was the initial approach for the index surgical procedure? were there any intra-operative complications? were any concomitant procedures performed? were any concurrent devices implanted? what symptoms did the patient experience following the index surgical procedure? onset date? can you provide more detail on the type of micturition issue(s) experienced by the patient? describe any medical/surgical intervention including dates and findings.Were any deficiencies or anomalies noted with mesh device upon removal? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? attempts are being made to retrieve the device.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.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19164898
• MDR Text Key: 340840511
• Report Number: 2210968-2024-04799
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810081L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2024
• 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 Age: 69 YR