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

Catalog Number TVTS4

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Fistula (1862); Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571); Drainage (2602)

Event Date 02/02/2012

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure to treat stress urinary incontinence on (b)(6) 2007 and mesh was implanted.The patient experienced pelvic pain and dyspareunia with erosion of the mesh through the vaginal wall that required removal on (b)(6) 2012.In 2013, the patient developed an area on the outer labia that would fill and spontaneously drain.The area was treated with clotrimazole-betamethasone 1%-0.05% cream twice daily for 2 weeks without resolution.The patient also had a urinary tract infection that was treated with cipro.The patient returned to the clinic in 2013 with the same symptoms.She underwent a transvaginal ultrasound for evaluation and diagnosis of perineal fistula formation.The patient is to undergo exploration of fistula and possible removal of additional mesh.No further information was provided.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.This medwatch report is in response to receipt of maude event report mw5035595.

Manufacturer Narrative

Date sent to the fda: 11/20/2015.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3842824
• MDR Text Key: 4683893
• Report Number: 2210968-2014-06906
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3018610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention