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

Model Number 810081L

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Pocket Erosion (2013); Urinary Frequency (2275)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent mesh excision on (b)(6) 2017 due to urinary urgency, frequency, dyspareunia, mesh erosion and pain.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # psr-60556 for previously submitted mdr number 2210968-2018-72083, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).

• 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
• MDR Report Key: 12660286
• MDR Text Key: 283767751
• Report Number: 2210968-2021-09921
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR