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

Catalog Number TVTS4

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); 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 a gynecological procedure on (b)(6) 2008 and a sling was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue, recurrence 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 secur system - (b)(4).

Manufacturer Narrative

(b)(4).

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(b)(4).

Manufacturer Narrative

(b)(4).

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(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

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(b)(4).Reporting period (b)(6) 2014 through (b)(4) 2015.

Manufacturer Narrative

Date sent to the fda: 06/20/2016.(b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2015.

Manufacturer Narrative

(b)(4).

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(b)(4).

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Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2014 through (b)(4) 2015.

Manufacturer Narrative

(b)(4).Reporting period december 1, 2014 through january 31, 2015.Supplemental 13.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2014 through (b)(6) 2015 supplemental 15 - attachment: [(b)(6) 2015 pah supplemental 15.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

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

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Corrected information: marker file ¿12-31-2014 ftl supplemental 23¿ was incorrectly submitted on 10/26/2018 via manufacturer report number 2210968-2014-15475 and will be correctly submitted via 2210968-2014-12913.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2014 through january 31, 2015.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2014 through january 31, 2015.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4545671
• MDR Text Key: 5510536
• Report Number: 2210968-2014-15475
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3101579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2007
• 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: 49 YR
• Patient Weight: 75