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

Catalog Number 810081

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a sling procedure on (b)(6) 2006 along with removal of iucd and insertion of mirena ius.At a follow up appointment in (b)(6) 2006, mild rectocele was found with lax perineum.During physiotherapy, it was noted that the tape was palpable within the vagina and tape erosion was found.The patient remained incontinent during intercourse.The patient also had lower abdominal discomfort and was treated with antibiotic therapy.On (b)(6) 2007, the patient underwent a surgical procedure to repair the tissue around the mesh exposure.In (b)(6) 2007, the patient said, she could feel exposed mesh and had pain and discharge and complained of discomfort during intercourse.The symptoms of stress incontinence had returned.Exposed tape was found in the anterior vaginal vault.On (b)(6) 2007, exposed mesh was excised.On (b)(6) 2010, the patient was suffering from an increased dragging sensation in her vagina and a recurrence of stress incontinence.In (b)(6) 2010, the patient experienced marked coital incontinence and was having problems emptying her bowel.On (b)(6) 2011, the patient had a retro pubic sling inserted and an anterior repair was performed.Further surgery was performed in 2012 to cut the mesh away.

Manufacturer Narrative

The patient experienced urinary tract infections and dyspareunia.(b)(4).

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.

• Brand Name: GYNECARE TVT OBTURATOR 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3577006
• MDR Text Key: 4057601
• Report Number: 2210968-2014-00345
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: No
• 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