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

Catalog Number 810081L

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Incontinence (1928); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent an obturator sling procedure on an unknown date.Post operatively, the patient experienced a vaginal erosion/exposure of the mesh.The patient is currently being managed with estrogen cream.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

It was reported that the procedure was performed on (b)(6) 2012.The patient concomitantly underwent a left labial trimming procedure.The patient began to experience stress incontinence again on (b)(6) 2014 and complained that the tape had slipped.The surgeon could not confirm any movement of the mesh.Currently, the patient is waiting for surgery.The plan is to cut the tape and sew the epithelium.(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3947915
• MDR Text Key: 4643380
• Report Number: 2210968-2014-09757
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

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: 06/30/2013
• Device Catalogue Number: 810081L
• Device Lot Number: 3632381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 07/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2012
• 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