MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - SECUR; MESH, SURGICAL

Catalog Number TVTS

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).Reporting period april 1, 2018 through may 31, 2018 total number of events ¿ (b)(4) tension free vaginal tape ¿ secur - (b)(4).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and mesh was implanted.It was reported that she experienced undisclosed injuries.No additional information was provided.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Pc-(b)(4).Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2018 through (b)(4) 2018.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 2/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 2/17/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 06/23/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 02/22/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

Manufacturer Narrative

Date sent to fda: 04/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2018 through may 31, 2018.

• Brand Name: TENSION FREE VAGINAL TAPE - SECUR
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7638926
• MDR Text Key: 112412271
• Report Number: 2210968-2018-73835
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2018

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: 12/31/2009
• Device Catalogue Number: TVTS
• Device Lot Number: 3116768
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 12/19/2019; 02/17/2020; 06/23/2020; 02/22/2021; 04/20/2021
• Supplement Dates FDA Received: 08/17/2018; 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 12/19/2019; 02/17/2020; 06/23/2020; 02/22/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR