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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810041B
Device Problem Migration (4003)
Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Pain (1994); Hematuria (2558); Not Applicable (3189)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5086250-1.
 
Event Description
It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted.The patient experienced blood in urine with severe abdominal pain.Initial diagnosis was a bladder stone, and the patient was referred to the urologist.After cystoscopy and surgery, it was discovered the mesh infiltrated the bladder which allows calculi to grow on it.The patient underwent a first interventional surgery since 2018.
 
Manufacturer Narrative
The 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 DEVICE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8725551
MDR Text Key148922618
Report Number2210968-2019-83132
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000322
UDI-Public10705031000322
Combination Product (y/n)N
PMA/PMN Number
K012628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/06/2019
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 Date10/31/2016
Device Catalogue Number810041B
Device Lot Number3732905
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/06/2019
Initial Date FDA Received06/23/2019
Supplement Dates Manufacturer Received06/21/2019
Supplement Dates FDA Received07/01/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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