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); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 06/28/2017.(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(6).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and the mesh was implanted.Following the procedure, the patient experienced pain and erosion and underwent revision procedures.No further information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(4), 2017 through (b)(4) 2017.

Manufacturer Narrative

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

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period april 1, 2017 through may 31, 2017.Supplemental 02 - attachment: [(b)(4).Pah supplemental 02.Xlsx].

Manufacturer Narrative

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

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(4) 2017 through (b)(4) 2017.Supplemental 06 - attachment: [(b)(4) 2017 pah supplemental 06.(b)(4).].

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Date sent to fda: 10/28/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period april 1, 2017 through may 31, 2017.

• 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: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6675116
• MDR Text Key: 78654618
• Report Number: 2210968-2017-03090
• 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: 03/13/2017

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: 04/30/2011
• Device Catalogue Number: TVTS4
• Device Lot Number: 3308708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 03/10/2017; 03/10/2017; 03/10/2017; 03/10/2017; 03/10/2017; 03/10/2017; 03/10/2017; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 10/28/2019
• Supplement Dates FDA Received: 08/29/2017; 10/25/2017; 12/27/2017; 02/22/2018; 04/12/2018; 06/25/2018; 08/17/2018; 10/25/2018; 12/27/2018; 02/12/2019; 04/23/2019; 10/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2009
• 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: 80 YR