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

Catalog Number TVTS4

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Date 05/18/2015

Event Type  Injury  

Manufacturer Narrative

The mesh was excised on (b)(6) 2015.Upon removal of the mesh, partial erosion of the vaginal mesh was noted.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2007 and mid-urethral sling was implanted.Following the procedure, the patient experienced painful intercourse.On pelvic exam, partial erosion of the graft was found.The patient underwent an excision of exposed part of the graft.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This medwatch report is in response to receipt of voluntary mw 180012-2015-0007.

• 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 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4860408
• MDR Text Key: 16352448
• Report Number: 2210968-2015-07382
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3049068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2007
• 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
• Patient Age: 44 YR
• Patient Weight: 112