LANGSTON V2 5540

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 2020-02-07 for LANGSTON V2 5540 manufactured by Vascular Solutions, Llc.

MAUDE Entry Details

Report Number2134812-2020-00011
MDR Report Key9681779
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-07
Date of Report2020-01-17
Date of Event2020-01-17
Date Mfgr Received2020-01-17
Device Manufacturer Date2019-11-01
Date Added to Maude2020-02-07
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 ContactMS. MARY HAUFEK
Manufacturer Street6464 SYCAMORE COURT NORTH
Manufacturer CityMINNEAPOLIS MN 55369
Manufacturer CountryUS
Manufacturer Postal55369
Manufacturer Phone7636564230
Manufacturer G1VASCULAR SOLUTIONS, LLC
Manufacturer Street6464 SYCAMORE COURT NORTH
Manufacturer CityMINNEAPOLIS MN 55369
Manufacturer CountryUS
Manufacturer Postal Code55369
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLANGSTON V2
Generic NameDUEL LUMEN
Product CodeDQO
Date Received2020-02-07
Returned To Mfg2020-01-21
Model Number5540
Lot Number660910
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVASCULAR SOLUTIONS, LLC
Manufacturer Address6464 SYCAMORE COURT NORTH MINNEAPOLIS MN 55369 US 55369


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-07

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