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); Erosion (1750); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a surgical procedure on (b)(6) 2005 and a sling was implanted.The patient experienced urgency and frequency, problems emptying her bladder, pain, erosion of her internal bodily tissue and other injuries following the procedure.The surgeon opined that the patient could have a degree of detrusor over activity and the patient was started on detrusitol.It was reported that the patient has undergone multiple surgeries and revisionary procedures.On (b)(6) 2006, she was admitted to the hospital and underwent a cystoscopy and division of the mesh.On (b)(6) 2007, the patient underwent a diagnostic laparoscopy to investigate pelvic pain.Multiple adhesions were seen and divided.On (b)(6) 2008, the patient underwent another sling procedure, cystoscopy and cystodistension.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.

• 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: 3576695
• MDR Text Key: 19584993
• Report Number: 2210968-2014-00338
• 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
• Report Date: 01/03/2014

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: 02/28/2006
• Device Catalogue Number: 810081
• Device Lot Number: 1290519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/24/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention