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

Catalog Number TVTS1

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This medwatch report is being submitted due to a request from the fda to resend the missing initial report.(b)(4).Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008, and a mesh was implanted due to sui.It was reported that the patient experienced multiple complications, including erosion, formation of scar tissue, additional surgeries and neurologic compromise to her structures and tissues.It was reported that following insertion the patient experienced pain, erosion, extrusion, infection, urinary problems, fistulae, bleeding and vaginal scarring.It was reported that the patient underwent mesh excision and anterior colporrhaphy on (b)(6) 2011.No additional information has been provided.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON, INC.; po box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON - SARL; puits-godet 20; neuchatel, 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; po box 151, route 22 west; somerville, NJ 08876
• MDR Report Key: 10977165
• MDR Text Key: 220498165
• Report Number: 2210968-2015-19256
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: TVTS1
• Device Lot Number: 3135703
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2008
• 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