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

Catalog Number TVTS4

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Pain (1994); No Code Available (3191)

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).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted.Following the procedure, the patient experienced pain and erosion and has undergone multiple surgeries and revisionary procedures, including a mesh removal surgery on (b)(6) 2014.The patient underwent another surgery on (b)(6) 2015 to treat vaginal prolapse.No additional information was provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Date sent to the fda: 02/23/2017.(b)(4).Reporting period august 1, 2016 through september 30, 2016.Supplemental 02.

Manufacturer Narrative

(b)(4).Reporting period (b)(6) 2016.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Date sent to the fda: 08/29/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2016 through (b)(4) 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2016 through (b)(4) 2016.

Manufacturer Narrative

Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Date sent to fda: 10/28/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2016 through september 30, 2016.

Manufacturer Narrative

Date sent to fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period august 1, 2016 through september 30, 2016.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6061871
• MDR Text Key: 58598779
• Report Number: 2210968-2016-33216
• 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,Followup,Followup,Followup,Followup
• Report Date: 07/28/2016

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: 09/30/2011
• Device Catalogue Number: TVTS4
• Device Lot Number: 3374700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 07/25/2016; 07/25/2016; 07/25/2016; 07/25/2016; 07/25/2016; 07/25/2016; 07/25/2016; 10/26/2018; 12/27/2018; 02/12/2019; 04/24/2019; 10/28/2019; 12/19/2019
• Supplement Dates FDA Received: 12/20/2016; 02/23/2017; 04/20/2017; 06/28/2017; 08/29/2017; 10/24/2017; 12/27/2017; 02/22/2018; 04/12/2018; 06/22/2018; 08/16/2018; 10/26/2018; 12/27/2018; 02/12/2019; 04/24/2019; 10/28/2019; 12/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2009
• 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