Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE
  • 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; MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE Back to Search Results
Model Number EXACT TVTRL
Device Problem Device Inoperable (1663)
Patient Problem Urinary Retention (2119)
Event Date 02/12/2016
Event Type  Injury  
Event Description
Patient desired to have vaginal mesh removed due to urinary retention.About a month ago, patient underwent uterosacral suspension (intra-peritoneal), tvt exact mid-urethral sling performed.Ethicon (j&j) tvt exact tvtrl gynecare.Now patient has had a vaginal, revision or removal or removal of prosthetic vaginal graft, vaginal approach, cystoscopy.H&p: follow-up of incomplete bladder emptying s/p tvh, bso, uss, tvt, cysto about a month ago.She has had trouble with urinary retention, but passed her voiding trial in clinic.After she got home, she was again unable to void on the commode or in the bathtub.She went to the er, and had a foley catheter placed with a bladder volume of >800ml.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GYNECARE TVT
Type of Device
MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE
Manufacturer (Section D)
ETHICON, INC.
route 22 west p.o. box 151
somerville NJ 08876
MDR Report Key5488628
MDR Text Key39946841
Report Number5488628
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/23/2016,03/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberEXACT TVTRL
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2016
Event Location Hospital
Date Report to Manufacturer02/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
Patient Weight77
-
-