MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041BL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.Other procedure is captured in a separate file.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 07/28/2020 additional information: d4, h4 a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

• Brand Name: TVT DEVICE LCM
• 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: 10325710
• MDR Text Key: 200392581
• Report Number: 2210968-2020-05537
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

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
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 830041BL
• Device Lot Number: 3530117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention