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

Catalog Number 810081

Device Problem Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Bleeding (1738); Erosion (1750); Calcium Deposits/Calcification (1758); Incontinence (1928); Internal Organ Perforation (1987); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and a mesh was implanted.It was reported that following insertion the patient experienced pain, erosion, urinary/bowel problems, organ perforation, recurrence, bleeding and dyspareunia.It was reported that the patient underwent bilateral retrograde pyelogram due to right flank pain, bladder debris and atrophic right kidney on (b)(6) 2009, right laparoscopic nephrectomy and laparoscopic lysis of adhesions due to atrophic right kidney and ruq adhesions on (b)(6) 2009 and left retrograde pyelogram, left flexible ureteroscopy and left double-j ureteral stent insertion (24cm x 5 french) due to randall¿s plaques in the left kidney on (b)(6) 2010.(b)(4).

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and mesh were implanted due to stress urinary incontinence.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, including a mesh removal surgery on (b)(6) 2013 and (b)(6) 2007 and due to vaginal mesh erosion.No additional information was provided.

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.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced urinary incontinence.It was reported that the patient underwent cystoscopy and coaptite injection on (b)(6) 2008.

• 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3578514
• MDR Text Key: 12399960
• Report Number: 2210968-2014-00380
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• 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
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2006
• Device Catalogue Number: 810081
• Device Lot Number: 1361107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2005
• 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: 59 YR
• Patient Weight: 62