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); 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 the patient underwent a gynecological procedure on (b)(6) 2008 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.No additional 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.

Manufacturer Narrative

(b)(4).It was reported that the patient had a gynecological procedure in order to treat stress urinary incontinence and menorrhagia and mesh was implanted.It was reported that the patient had a concurrent procedure of a hysterectomy performed during mesh implantation.It was reported that following insertion the patient experienced infection, urinary and bowel problems, dyspareunia and vaginal scarring.It was reported that the patient underwent partial removal of mesh sling on (b)(6) 2012, along with trachelectomy & anterior and posterior repair due to pelvic pain, vaginal prolapse, & failure of prior mesh with band syndrome.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure and mesh was implanted along with concurrent left salpingo-oophorectomy and cystoscopy.

Manufacturer Narrative

• 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: 3589470
• MDR Text Key: 4142203
• Report Number: 2210968-2014-00722
• 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
• Report Date: 10/25/2016

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: 04/30/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3031357
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 01/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/07/2014; 11/26/2014; 11/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2007
• 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: 37 YR
• Patient Weight: 93