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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 Pain (1994); Burning Sensation (2146)
Event Date 05/05/2010
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 3371427 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 gynecological procedure on (b)(6) 2010 and the mesh was implanted.It was reported that the patient experienced pain and burning sensations in the pelvic girdle, hip pain, sacral pain, and pinching in the vagina.
 
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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 Key12212004
MDR Text Key265646857
Report Number2210968-2021-06593
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 Date09/30/2012
Device Model Number810081
Device Catalogue Number810081
Device Lot Number3371427
Was Device Available for Evaluation? Yes
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 Manufactured10/09/2009
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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