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

Catalog Number 810041B

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent that a patient underwent sling procedure on (b)(6) 2011.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that 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 - (b)(4).Gynecare tvt - 203.Gynecare tvt abrevo continence system - (b)(4).Gynecare tvt exact continence system - (b)(4).Gynecare tvt obturator system - (b)(4).Gynecare tvt retropubic system - (b)(4).Gynecare tvt-aa abdominal - (b)(4).

Manufacturer Narrative

The indication for procedure was stress urinary incontinence.It was reported that following insertion the patient experienced pain, infection, urinary problems, organ perforation, and recurrence.(b)(4).

Manufacturer Narrative

(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(6) 2014.

Manufacturer Narrative

(b)(4).Reporting period (b)(4) 2014.

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(b)(4).

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(b)(4).Reporting period october 1 2014 through november 30, 2014.

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(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).

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(b)(4).Reporting period october 1 2014 through november 30, 2014.

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(b)(4).

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(b)(4).

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Date sent to the fda: 12/20/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to fda: 12/26/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to the fda: 10/28/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1 2014 through november 30, 2014.

Manufacturer Narrative

Date sent to fda: 06/23/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2014 through november 30, 2014.

• Brand Name: GYNECARE TVT RETROPUBIC 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: 4370478
• MDR Text Key: 5286850
• Report Number: 2210968-2014-12562
• 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: Invalid Data
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/04/2014

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: 02/28/2014
• Device Catalogue Number: 810041B
• Device Lot Number: 3500111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 12/30/2014
• 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; Not provided; Not provided; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 09/03/2014; 10/26/2018; 12/26/2018; 02/12/2019; 04/24/2019; 10/28/2019; 06/23/2020
• Supplement Dates FDA Received: 02/24/2015; 04/29/2015; 06/22/2015; 10/27/2015; 12/21/2015; 02/23/2016; 04/21/2016; 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; 12/20/2017; 02/27/2018; 04/18/2018; 06/21/2018; 08/16/2018; 10/28/2018; 12/26/2018; 02/12/2019; 04/24/2019; 10/28/2019; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR