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

Catalog Number 810081L

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).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Total number of events ¿ (b)(4).Gynecare tvt ¿ (b)(4).Gynecare tvt abbrevo ¿ (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).

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 due to uterine prolapse, cystocele, rectocele and stress urinary incontinence.Following the procedure, the patient experienced pain and erosion and underwent revision surgeries.No further information is available.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2016.

Manufacturer Narrative

Date sent to the fda: 04/20/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(4) 2016.

Manufacturer Narrative

Date sent to the fda: 08/29/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.Supplemental 05 - attachment: [(b)(4) otn supplemental 05.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period (b)(4) 2016 through (b)(4) 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2016 through (b)(6) 2016 supplemental 06 - attachment: [(b)(6) 2016 otn supplemental 06.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2016 through (b)(4) 2016.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 6/25/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 02/17/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 10/282019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 04/19/2021.

Manufacturer Narrative

Date sent to fda: 06/18/2021.

• Brand Name: GYNECARE TVT OBTURATOR 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6195521
• MDR Text Key: 63050019
• Report Number: 2210968-2016-34462
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Catalogue Number: 810081L
• Device Lot Number: 3238501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2008
• 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: 73 YR