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

Catalog Number 810081L

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Date 01/10/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an obturator sling procedure on an unknown date.The patient experienced a mesh exposure.The patient underwent another procedure to excise the exposed mesh segment.Additional information has been requested.

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.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 anterior and posterior colporrhaphy on (b)(6) 2010.The patient experienced pain immediately after the procedure.The mesh exposure was first noted by a physician on (b)(6) 2013 in right vaginal sulcus with visual diagnostic confirmation.The patient received a course of metronidazole and received further review and was offered removal.The patient underwent a surgical procedure on (b)(6) 2014 for exposure.It was reported that the patient is currently experiencing recurrent stress urinary incontinence and ongoing right hip and leg pain.(b)(4).

• 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 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4973816
• MDR Text Key: 6338671
• Report Number: 2210968-2015-10886
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: 810081L
• Device Lot Number: 3522238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2011
• 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: 39 YR
• Patient Weight: 85