GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET G52916 IGTCFS-65-1-JUG-TULIP

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 2020-03-30 for GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET G52916 IGTCFS-65-1-JUG-TULIP manufactured by William Cook Europe.

MAUDE Entry Details

Report Number3002808486-2020-00374
MDR Report Key9896430
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-17
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-11-25
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. THOMAS HESSNER KIRK
Manufacturer StreetSANDET 6
Manufacturer CityBJAEVERSKOV DK-4632
Manufacturer CountryDA
Manufacturer PostalDK-4632
Manufacturer Phone56868686
Manufacturer G1WILLIAM COOK EUROPE
Manufacturer StreetSANDET 6
Manufacturer CityBJAEVERSKOV DK-4632
Manufacturer CountryDA
Manufacturer Postal CodeDK-4632
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Generic NameDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Product CodeDTK
Date Received2020-03-30
Model NumberG52916
Catalog NumberIGTCFS-65-1-JUG-TULIP
Lot NumberE3925585
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWILLIAM COOK EUROPE
Manufacturer AddressSANDET 6 BJAEVERSKOV 4632 DA 4632


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.