MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810081

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Surgical procedure (2357); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and a sling was implanted.The patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.The patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).Total number of events - 1175.Gynecare tvt - 96.Gynecare tvt abrevo continence system - 67.Gynecare tvt exact continence system - 98.Gynecare tvt obturator system - 493.Gynecare tvt retropubic system -349.Gynecare tvt-aa abdominal - 72.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

(b)(4).Reporting period (b)(4) 2015.

Manufacturer Narrative

Date sent to the fda: 04/22/2016.(b)(4).Reporting period february 1, 2015 through march 31, 2015, supplemental 06.

Manufacturer Narrative

It was reported that the patient concurrently underwent ligation tubal laparoscopic via filshe clips.

Manufacturer Narrative

Ethicon mdr summary reporting exemption e2013037.Reporting period (b)(6) 2015 through (b)(6) 2015.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(6).Reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 12 (b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2015.Supplemental 13.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 15 - attachment: [(b)(6) 2015 otn supplemental 15.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 16 - attachment: [(b)(6) 2015 otn supplemental 16.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Date sent to fda: 04/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Date sent to fda: 12/20/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.

Manufacturer Narrative

Date sent to fda: 06/23/2020.

Manufacturer Narrative

Date sent to fda: 06/18/2021.

Manufacturer Narrative

Date sent to fda: 08/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.

• Brand Name: GYNECARE TVT OBTURATOR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 4734343
• MDR Text Key: 5582764
• Report Number: 2210968-2015-00138
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/16/2016

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: 06/30/2007
• Device Catalogue Number: 810081
• Device Lot Number: 2935167
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 05/16/2016; 05/16/2016; 05/16/2016; 05/16/2016; 05/16/2016; 05/16/2016; 05/16/2016; 10/26/2018; 12/27/2018; 02/12/2019; 04/23/2019; 12/20/2019; 06/23/2020; 06/18/2021; 08/20/2021
• Supplement Dates FDA Received: 06/22/2015; 12/21/2015; 02/23/2016; 04/22/2016; 05/31/2016; 06/21/2016; 08/23/2016; 10/26/2016; 12/19/2016; 02/23/2017; 04/19/2017; 06/27/2017; 08/28/2017; 10/23/2017; 12/21/2017; 02/26/2018; 04/17/2018; 06/21/2018; 08/16/2018; 10/28/2018; 12/27/2018; 02/12/2019; 04/23/2019; 12/20/2019; 06/23/2020; 06/18/2021; 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR