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 Other (for use when an appropriate patient code cannot be identified) (2200); Discomfort (2330); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2013 and an obturator sling was implanted.The patient returned to the physician for discomfort from exposed mesh on the right side of the vaginal sulcus on (b)(6) 2014.She then saw a uro-gynecology specialist and underwent a procedure to bury the exposed mesh on (b)(6) 2014.Follow up exam in (b)(6) 2014 showed that mesh remained exposed.The patient is currently waiting to have a cystoscopy and removal of exposed mesh.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 a patient underwent a gynecological procedure on (b)(6) 2013 concurrently with laparoscopic sterilization.The patient experienced discomfort on (b)(6) 2014 in the vaginal wall.During the re-operation on (b)(6) 2014, exposed mesh 1 cm area under right side of pubic ramus was found.It was reported that the patient is still having vaginal symptoms and awaiting further surgery to remove the exposed mesh and cystoscopy.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4788993
• MDR Text Key: 5859702
• Report Number: 2210968-2015-06217
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 810081L
• Device Lot Number: 3612222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2012
• 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
• Patient Age: 42 YR
• Patient Weight: 73