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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT OBTURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810081
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); Surgical procedure (2357); Blood Loss (2597); No Code Available (3191)
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) 2015 supplemental 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.
 
Manufacturer Narrative
Date sent to fda: 2/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 04/23/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 12/20/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 06/23/2020.
 
Manufacturer Narrative
Date sent to fda: 06/18/2021.
 
Manufacturer Narrative
Date sent to fda: 08/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period february 1, 2015 through march 31, 2015.
 
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Brand Name
GYNECARE TVT OBTURATOR SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key4734343
MDR Text Key5582764
Report Number2210968-2015-00138
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
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
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age31 YR
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