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

Catalog Number TVTS4

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Scar Tissue (2060); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Total number of events ¿ (b)(4).Gynecare tvt secur system - (b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent a gynecological procedure on(b)(6) 2009 and a sling was implanted.The patient experienced pain, erosion of 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).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that the patient concurrently underwent cystoscopy.

Manufacturer Narrative

Date sent to the fda: 06/21/2016.(b)(4).Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(6) 2015 through (b)(6) 2015.Supplemental 06.

Manufacturer Narrative

Date sent to the fda: 02/23/2017.(b)(4).Reporting period october 1, 2015 through november 30, 2015.Supplemental 07.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 12 - attachment: [(b)(6) 2015 pah supplemental 12.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2015 through (b)(4) 2015.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2015 through november 30, 2015.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2015 through november 30, 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: 5315260
• MDR Text Key: 34014700
• Report Number: 2210968-2015-13970
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3016732
• 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: 03/21/2007
• 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: 108