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

Model Number 810081

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2018 through november 30, 2018.(b)(4).Total number of events ¿ 644.Tension free vaginal tape - 210; tension free vaginal tape ¿ abbrevo - 15; tension free vaginal tape ¿ abdominal - 12; tension free vaginal tape ¿ exact - 40; tension free vaginal tape ¿ obturator - 265; tension free vaginal tape ¿ retropubic - 102.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and the mesh was implanted.It was reported that she experienced dyspareunia and erosion.It was also reported that the patient has undergone revisionary procedures.No further information is available.

Manufacturer Narrative

Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 6/25/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 8/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 10/25/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 04/21/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to the fda: 8/24/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2018 through september 31, 2018.

Manufacturer Narrative

Date sent to the fda: 08/25/2020.Corrected narrative for follow up number 7: ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8202990
• MDR Text Key: 131619140
• Report Number: 2210968-2018-78065
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2008
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3002693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Patient Sequence Number: 1
• Treatment: PROLIFT; PROLIFT
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR