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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYNECARE/ETHICON TVT EXACT; MESH

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GYNECARE/ETHICON TVT EXACT; MESH Back to Search Results
Model Number TVTRL
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hair Loss (1877); Incontinence (1928); Itching Sensation (1943); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Weakness (2145); Ambulation Difficulties (2544); Weight Changes (2607)
Event Date 12/15/2011
Event Type  Injury  
Event Description
In (b)(6) of 2011, i was implanted with a retro-public sling (gynecare tvt exact, tvtrl, sterile eo lot 3564380.From the very start of implantation of this vaginal sling, i have had side effects.Could not pass urine, went home with a cath, 6 days later, it was removed.Within an hr of arriving home, the severe deep pain in my lower back began.I could not stand up straight, sit, or walk.Crawling was the only was i could get around and continues on and off in spells to date.Once i could lay down, severe pain would radiate down both my legs to my toes.There is no position that i can lay to relieve this pain.The longer i lay the harder it is for me to move my legs at all and still occurs to date.Six weeks after began total incontinence, i am not aware that this will occur, developed lichen sclerosis, loss of hair, itching, unsteady gait, weight gain to pounds, swelling of legs, feet and stomach daily, bladder infections.Over all health now is bad.I am always at the doctors.Loosing control of my bowels when i cough.I was a very physically active woman.Sex is very painful.I can't even stand at the sink and wash all the dishes.
 
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Brand Name
TVT EXACT
Type of Device
MESH
Manufacturer (Section D)
GYNECARE/ETHICON
MDR Report Key4068388
MDR Text Key16854651
Report NumberMW5038083
Device Sequence Number1
Product Code OTN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date12/15/2011
Device Model NumberTVTRL
Device Lot Number3564380
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
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