TVT EXACT RETROPUBIC SYSTEM TVTRL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for TVT EXACT RETROPUBIC SYSTEM TVTRL manufactured by Ethicon Inc..

Event Text Entries

[186697356] (b)(4). A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified. 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Please confirm if mesh product tvtrl with lot number 3931358 was implanted in (b)(6) 2018? Were there any intra-operative complications during (b)(6) 2018 initial surgery? Other relevant patient comorbidities/concomitant medications? Mesh exposure site/location and diagnostic confirmation? Please clarify? Contact hemorrhage? And the volume of bleeding? How the bleeding was treated? Results? Were cultures performed? Results? What is physician? S opinion as to the etiology of or contributing factors to these events (hemorrhage and mesh erosion)? What is the patient's current status? The patient demographic info: age, weight, bmi at the time of index procedure?
Patient Sequence No: 1, Text Type: N, H10


[186697357] It was reported that the patient underwent a sling procedure on (b)(6) 2018 and the mesh was implanted due to urinary stress incontinence. On (b)(6) 2020 the patient was seeing by doctor due to mesh erosion suspicion. The patient presented contact hemorrhage and foreign body sensation in vagina. At the examination, mesh exposure was found just below meatus urethra with irritation of the surrounding tissue. On (b)(6) 2020 the exposed mesh sling part was removed and sent for cultivation for actinomyces. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02421
MDR Report Key9888911
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-27
Date of Report2020-03-02
Date of Event2020-02-10
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-01-30
Date Added to Maude2020-03-27
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 NameTVT EXACT RETROPUBIC SYSTEM
Generic NameMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Product CodeOTN
Date Received2020-03-27
Model NumberTVTRL
Catalog NumberTVTRL
Lot Number3931358
Device Expiration Date2018-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-27

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