TENSION FREE VAGINAL TAPE - SECUR TVTS4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-24 for TENSION FREE VAGINAL TAPE - SECUR TVTS4 manufactured by Ethicon Inc..

Event Text Entries

[185912237] (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.
Patient Sequence No: 1, Text Type: N, H10


[185912238] It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted. It was reported that she experienced undisclosed injuries. It was reported that the patient underwent a revision surgery on (b)(6) 2010. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-00652
MDR Report Key9628925
Report SourceFOREIGN,OTHER
Date Received2020-01-24
Date of Report2020-01-21
Date Mfgr Received2020-03-02
Device Manufacturer Date2009-06-15
Date Added to Maude2020-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON SARL-NEUCHATEL
Manufacturer StreetPUITS-GODET 20
Manufacturer CityNEUCHATEL
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTENSION FREE VAGINAL TAPE - SECUR
Generic NameMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Product CodePAH
Date Received2020-01-24
Catalog NumberTVTS4
Lot Number3322095
Device Expiration Date2011-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-24

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