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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 Migration (4003)
Patient Problems Erosion (1750); Pain (1994); Scarring (2061)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced pain, urethral scarring, mesh exposure following the surgery.It was reported that the patient underwent removal surgery on (b)(6) 2020.No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 11/15/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
GYNECARE TVT OBTURATOR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10818126
MDR Text Key215583041
Report Number2210968-2020-08784
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000346
UDI-Public10705031000346
Combination Product (y/n)N
PMA/PMN Number
K181151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Model Number810081
Device Catalogue Number810081
Device Lot Number3796503
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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