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

Catalog Number 810081

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); 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 a patient underwent an obturator sling procedure on (b)(6) 2006.In (b)(6) 2009, the patient experienced recurrent urinary tract infections and mixed incontinence.On examination, she was tender over her urethra and there was marked leakage on coughing with some descent.A urinary tract infection was confirmed and she was treated with antibiotics.Urodynamics confirmed that she had a low capacity bladder with over-activity, some urgency with urge incontinence and stress incontinence.Cystoscopy showed an erosion of the mesh on the left side of the urethra.The patient was prescribed a low dose antibiotic prophylaxis in an attempt to control the urinary tract infections.The patient underwent a procedure for mesh removal on (b)(6) 2009 and it was noted the mesh eroded into the lumen of the urethra and into the bladder.The urethral defect created by the removal of the tape was 1.5cm in length.Urodynamic evaluation demonstrated severe stress incontinence with a low urethral closure pressure.The surgeon used a pubovaginal sling placed at the bladder neck on (b)(6) 2011.In (b)(6) 2012, the patient was referred back as her symptoms had returned.No further 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).

• 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: 3573727
• MDR Text Key: 4078184
• Report Number: 2210968-2014-00288
• 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,Followup
• Report Date: 12/31/2013

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 Catalogue Number: 810081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2013
• Initial Date FDA Received: 01/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: No
• 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