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

Catalog Number TVTS1

Device Problem Material Erosion (1214)

Patient Problems Bleeding (1738); Erosion (1750); Extrusion (1844); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a sling procedure to treat stress urinary incontinence on (b)(6) 2007.She concurrently underwent a tah, bso, subfascial hammock suspension, anterior colporrhaphy.It was reported that following insertion, the patient experienced pain, erosion, extrusion, infection, urinary/bowel problems, fistulae, recurrence, bleeding, dyspareunia, and vaginal scarring.No additional information was provided.

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.E2013037.Gynecare tvt secur system - 133.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The patient underwent mesh revision/removal on (b)(6) 2007 due mesh erosion.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 3897972
• MDR Text Key: 4648676
• Report Number: 2210968-2014-05569
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2014

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 Catalogue Number: TVTS1
• Device Lot Number: 2998103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/29/2014; 10/29/2014; 12/30/2014; 02/23/2015; 04/28/2015; 06/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2007
• 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: 31 YR
• Patient Weight: 72