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 Bleeding (1738); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by the patient that she underwent a gynecological procedure in 2010 and an obturator sling was implanted.Post procedure, the patient has experienced constant pressure, urinary frequency, a urinary tract infection for which she was treated, severe electric shock type pain inside the urethra, irregular bleeding and incontinence when coughing, laughing and sneezing.Additional information was not provided.

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.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4577545
• MDR Text Key: 5486303
• Report Number: 2210968-2015-02648
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/06/2015
• 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