• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810081
Device Problem Material Erosion
Event Type  Injury  
Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and a sling was implanted. The patient experienced pain, erosion of her 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). 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 - 1175. Gynecare tvt - 96. Gynecare tvt abrevo continence system - 67. Gynecare tvt exact continence system - 98. Gynecare tvt obturator system - 493. Gynecare tvt retropubic system -349. Gynecare tvt-aa abdominal - 72.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

(b)(4). Reporting period (b)(4) 2015.

 
Manufacturer Narrative

Date sent to the fda: 04/22/2016. (b)(4). Reporting period february 1, 2015 through march 31, 2015, supplemental 06.

 
Manufacturer Narrative

It was reported that the patient concurrently underwent ligation tubal laparoscopic via filshe clips.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption e2013037. Reporting period (b)(6) 2015 through (b)(6) 2015. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(6). Reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 12 (b)(4).

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period (b)(4) 2015. Supplemental 13.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4)reporting period (b)(6) 2015 through (b)(6) 2015supplemental 16 - attachment: [(b)(6) 2015 otn supplemental 16. Xlsx].

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period february 1, 2015 through march 31, 2015.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGYNECARE TVT OBTURATOR SYSTEM
Type of DeviceMESH, 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
SWITZERLAND
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville , NJ 08876
9082180707
MDR Report Key4734343
Report Number2210968-2015-00138
Device Sequence Number1
Product CodeOTN
Report Source Manufacturer
Source Type Other,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2007
Device Catalogue Number810081
Device LOT Number2935167
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/10/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/28/2015 Patient Sequence Number: 1
-
-