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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number 810081
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Inflammation (1932); Pain (1994); Burning Sensation (2146); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)
Event Date 04/23/2008
Event Type  Injury  
Manufacturer Narrative
(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3065992 and product code 810081.No additional information is available.If further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that a patient underwent a sling procedure on an unknown date in 2008 and the mesh was implanted.It was reported that the patient was not functional and had difficulty standing, sitting still, and a lot of burns on the hips and thighs.It was reported that the patient's groins, hips, and legs hurt.It was reported that the patient has a non-existent intimate relationship.It was reported that the patient had a small herniated disc on the scan.It was reported that the patient remained incontinent and drips upon trips to the bathroom at night.It was reported that the patient rises three to four times at night.The patient drips if the wait is too long to go to the bathroom during the day.It was reported that the patient had difficulty walking, and was diagnosed with two bursae in the buttocks and two bursae in the hips.It was reported that the patient was infiltrated without success.It was reported that the patient did physiotherapy because the pain went down to the lower legs.It was reported that the physiotherapist opined that the pain lessened as it went all the way down to the patient's thighs.It was reported that patient had problems with sciatica.It was also reported that the patient had difficulty going in and out of the car.It was also reported that the patient had difficulty sleeping and had to sleep on the back because lying on the sides were unbearable.For a short time the patient's labia majora went numb on the left and right side.The patient lost strength in the legs and had difficulty climbing the stairs.It was also reported that the patient saw a psychologist for depression.It was reported that the patient felt bad and useless with the pains because the patient was tired all the time and had not recovered.It was also reported that the patient had difficulty moving around.
 
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Brand Name
GYNECARE TVT OBTURATOR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12214964
MDR Text Key266057330
Report Number2210968-2021-06619
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000346
UDI-Public10705031000346
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2021
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 Health Professional
Device Expiration Date07/31/2008
Device Model Number810081
Device Catalogue Number810081
Device Lot Number3065992
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2007
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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