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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number TVTRL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); Foreign Body In Patient (2687)
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4)- device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
 
Event Description
It was reported that a patient underwent a sling procedure on (b)(6) 2019 and mesh was implanted.The patient reported experiencing severe pain immediately after in the groin, buttock and left leg with difficulty walking.The patient further reported pain in the 2 groins radiating in the front of the legs, difficulty sitting for a long time due to groin pain, stomach pain, pain during intercourse, impression of feeling the mesh in the groin and occasional internal burning sensation in the pubis.No further information is available.
 
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Brand Name
TVT EXACT RETROPUBIC SYSTEM
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 Key12196343
MDR Text Key262441206
Report Number2210968-2021-06487
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031062375
UDI-Public10705031062375
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
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 Date12/31/2019
Device Model NumberTVTRL
Device Catalogue NumberTVTRL
Device Lot Number3933644
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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