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

Catalog Number TVTS4

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Frequency (2275); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that following the procedure the patient experienced recurrence of sui, infections, urinary urgency, urinary frequency, perforation, fistula, pain, erosion of her internal bodily tissue and other injuries.It was reported that the patient underwent removal of mesh on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

(b)(4).This emdr represents supplemental report # 2210968-2016-03721 for previously submitted mdr number 2210968-2016-05590 subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.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.

• Brand Name: GYNECARE TVT SECUR -TENSION-
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12580870
• MDR Text Key: 282704426
• Report Number: 2210968-2021-09233
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 01/30/2011
• Device Catalogue Number: TVTS4
• Device Lot Number: 3270145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention