LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9040475600080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-16 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9040475600080 manufactured by Lutonix, Inc.

MAUDE Entry Details

Report Number3006513822-2020-00007
MDR Report Key9838320
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-18
Date Mfgr Received2020-02-18
Device Manufacturer Date2018-09-13
Date Added to Maude2020-03-16
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUTONIX 035 DRUG COATED BALLOON PTA CATHETER
Generic NameDRUG COATED BALLOON PTA CATHETER
Product CodePRC
Date Received2020-03-16
Model Number9004
Catalog Number9040475600080
Lot NumberGFDN2600
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLUTONIX, INC
Manufacturer Address9409 SCIENCE CENTER DR NEW HOPE MN 55428 US 55428


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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