WAVELINQ ENDOAVF SYSTEM FX-001CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-19 for WAVELINQ ENDOAVF SYSTEM FX-001CE manufactured by Tva Medical, Inc..

MAUDE Entry Details

Report Number3011392541-2019-00008
MDR Report Key8713001
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-06-19
Date of Report2019-06-19
Date of Event2019-05-23
Date Mfgr Received2019-05-23
Date Added to Maude2019-06-19
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 ContactJUDITH LUDWIG
Manufacturer Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1TVA MEDICAL, INC.
Manufacturer Street7000 BEE CAVE ROAD SUITE 250
Manufacturer CityAUSTIN TX 78746
Manufacturer CountryUS
Manufacturer Postal Code78746
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWAVELINQ ENDOAVF SYSTEM
Generic NameENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE
Product CodePQK
Date Received2019-06-19
Returned To Mfg2019-06-07
Model NumberFX-001CE
Catalog NumberFX-001CE
Lot NumberS0051
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTVA MEDICAL, INC.
Manufacturer Address7000 BEE CAVE ROAD SUITE 250 AUSTIN TX 78746 US 78746


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-19

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