*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-10-22 for * manufactured by Medtronic Perfusion Systems.

MAUDE Entry Details

Report Number2184009-2003-00066
MDR Report Key491891
Report Source05,06,07
Date Received2003-10-22
Date of Event2003-01-01
Date Mfgr Received2003-09-25
Date Added to Maude2003-10-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactLISA WEIK
Manufacturer Street8299 CENTRAL AVE NE
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635146694
Manufacturer G1MEDTRONIC PERFUSION SYSTEMS
Manufacturer Street7611 NORTHLAND DR
Manufacturer CityBRROKLYN PARK MN 55428
Manufacturer CountryUS
Manufacturer Postal Code55428
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic Name*
Product CodeDXS
Date Received2003-10-22
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key480591
ManufacturerMEDTRONIC PERFUSION SYSTEMS
Manufacturer Address7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-10-22

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