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); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report #2210968-2015-03725 for previously submitted mdr number 2210968-2015-02471, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.This case is being submitted to the fda for visibility in maude as an individual report; it was submitted prior in a summary report.Therefore, this report does not represent a new reportable event.(b)(4).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 by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.It was reported that following insertion the patient experienced extrusion, infection, recurrence, bleeding, neuromuscular problems and vaginal scarring.It was reported that patient underwent placement of interstim device on (b)(6) 2014.It was reported that patient underwent urethrolysis, anterior repair and mesh revision/excision on (b)(6) 2015 due to chronic pelvic pain with dyspareunia, voiding dysfunction, and mixed urinary incontinence.It was reported that the patient experienced nausea after the procedure.It was reported that patient underwent eua and removal of interstim lead, battery and generator on (b)(6) 2015 due to back pain, leg pain, dislodged interstim implant lead from surgical procedure.(as per operative report).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: 12717094
• MDR Text Key: 284458078
• Report Number: 2210968-2021-09765
• 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: 10/29/2021

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 Expiration Date: 12/31/2008
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3112713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 10/29/2021
• 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 Weight: 90