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 Fever (1858); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Other (for use when an appropriate patient code cannot be identified) (2200); Treatment with medication(s) (2571)

Event Date 06/08/2014

Event Type  Injury  

Event Description

It was reported by the patient that she underwent an obturator sling procedure on (b)(6) 2014.On (b)(6) 2014, the patient developed a fever of 103.6 and was admitted to the hospital.The patient stated she was never told what exactly the cause of the fever was, but had been referred for "cellulites" and then a blood clot.The patient was treated with two types of antibiotics.The patient still experiences leg and groin pain.The patient does not experience a sensation when she needs to urinate and is still has incontinence with sneezing.The patient requested sling removal two days afterwards, while in the hospital, but the physician refused to and told her the sling was fine.The patient is not able to function at the same level as prior to surgery.No further information was 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: 3963967
• MDR Text Key: 16850362
• Report Number: 2210968-2014-10253
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/29/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention