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); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.(b)(4).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and the mesh was implanted.Following the procedure, the patient experienced a mesh erosion and underwent a mesh excision on (b)(6) 2013.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 06/28/2017 ethicon mdr summary reporting (b)(4) reporting period (b)(6) 2017 supplemental 01 - attachment: [(b)(6) -2017 pah supplemental 01.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4), reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2017 through (b)(4) 2017.Supplemental 07 - attachment: [(b)(4) 2017 supplemental (b)(4)].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2017 through (b)(4) 2017.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 4/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 6/25/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 12/19/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 02/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2017 through march 31, 2017.

Manufacturer Narrative

Date sent to fda: 06/18/2021.

• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6508676
• MDR Text Key: 73326196
• Report Number: 2210968-2017-00629
• 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: 01/04/2017

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: 07/31/2010
• Device Catalogue Number: TVTS4
• Device Lot Number: 3195552
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: Not provided; 01/02/2017; 01/02/2017; 01/02/2017; 01/02/2017; 01/02/2017; 01/02/2017; 01/02/2017; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 06/25/2019; 12/19/2019; 02/18/2020; 04/19/2021; 06/18/2021
• Supplement Dates FDA Received: 06/28/2017; 08/29/2017; 10/25/2017; 12/27/2017; 02/22/2018; 04/12/2018; 06/22/2018; 08/17/2018; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 06/25/2019; 12/19/2019; 02/18/2020; 04/19/2021; 06/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2008
• 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
• Patient Age: 62 YR