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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT OBURATOR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Incontinence (1928); Pain (1994); Surgical procedure (2357)
Event Type  Injury  
Event Description
It was reported, by the patient, that she underwent a gynecological procedure to treat incontinence in 2009 and an obturator sling was implanted.The patient states that the sling has ruined her life and she is in constant severe pain in the vaginal area, left leg and both feet.She is incontinent of bowel and bladder, has severe mobility issues requiring a wheelchair, chronic fatigue, severe depression, and is suicidal.The patient underwent a removal procedure in 2013.Additional information was not provided.
 
Manufacturer Narrative
(b)(4) - incontinence occurred.Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
GYNECARE TVT OBURATOR SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20 2000 neuchatel
neuchatel
SZ  
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4610704
MDR Text Key15226798
Report Number2210968-2015-03142
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 Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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