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

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Obstruction/Occlusion (2422); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported in a literature review that the patient underwent sling procedure on an unknown date.Approximately 6-12 months following the procedure, the patient experienced post-operative groin pain, urinary stress incontinence, urinary urgency incontinence, bladder outlet obstruction, overactive bladder and vaginal exposure.The patient underwent re-intervention for vaginal exposure and reoperation for persistent urinary stress incontinence.The patient received post-operative analgesic treatment for pain management.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.(b)(4).

• Brand Name: GYNECARE TVT OBURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• 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: mary szaro ; 9082183464
• MDR Report Key: 4860429
• MDR Text Key: 16176522
• Report Number: 2210968-2015-07383
• 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,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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