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

Model Number 810081

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Incontinence (1928); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-73832, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological surgical procedure on 7/1/2005 and tvt obturator was implanted.It was reported that following insertion the patient experienced stress urinary incontinence and pelvic pain.It was reported that the patient underwent a mesh removal on (b)(6) 2012 due to adhesion and mesh erosion.No additional information was provided.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12708829
• MDR Text Key: 282004507
• Report Number: 2210968-2021-10387
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2006
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 1301581
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR