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

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Extrusion (1844); Inflammation (1932); Neuropathy (1983); Pain (1994); Pulmonary Dysfunction (2019); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Manufacturer Narrative

(b)(4) - psychiatric issues; symptoms of asia.Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.This medwatch report is in response to receipt of maude event report (b)(4).

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2008.The patient experienced an exacerbation of asthma immediately and developed symptoms of asia by 2011.The patient developed excruciating pelvic and rectal pain and was diagnosed with pudendal neuropathy secondary to mesh complications.The patient developed severe depression and was suicidal when the physician failed to diagnose internal mesh erosion.The patient had blue fragments coming out in her urine.The fibers caused inflammation of the skin around the genitalia.The patient was prescribed oxycodone and morphine to treat her pain.The patient underwent mesh removal on (b)(6) 2013.Months after the removal, the patient still had fibers in the urine which dwindled.The patient has extreme depression, ptsd and lethargy.No further information was provided.

• Brand Name: GYNECARE TVT SECUR 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: 4021427
• MDR Text Key: 21157217
• Report Number: 2210968-2014-11708
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• 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: 07/28/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention