MAUDE Adverse Event Report: ETHICON INC. TVT SECUR 1UP; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTS1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Incontinence (1928)

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted the adverse event which occurred on (b)(6) 2008.(b)(4) submitted the adverse event which occurred on (b)(6) 2011.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent revision of mesh on (b)(6) 2008 due to recurrent incontinence.It was reported that the patient underwent excision of mesh on (b)(6) 2011 due to erosion.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 12/2/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: TVT SECUR 1UP
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10912563
• MDR Text Key: 219365858
• Report Number: 2210968-2020-09405
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Catalogue Number: TVTS1
• Device Lot Number: 3047875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR