VENTANA HE 600 SYSTEM 06917259001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-13 for VENTANA HE 600 SYSTEM 06917259001 manufactured by Ventana Medical Systems Inc.

MAUDE Entry Details

Report Number2028492-2019-00017
MDR Report Key9049713
Date Received2019-09-13
Date of Report2019-09-13
Date of Event2019-05-31
Date Mfgr Received2019-08-16
Date Added to Maude2019-09-13
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 ContactNA STACIE-ANN CREIGHTON
Manufacturer Street1910 E INNOVATION PARK DR NA
Manufacturer CityTUSCON AZ 85755
Manufacturer CountryUS
Manufacturer Postal85755
Manufacturer Phone9082537112
Manufacturer G1NA
Manufacturer StreetNA NA
Manufacturer CityNA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameVENTANA HE 600 SYSTEM
Generic NameSLIDE STAINER, AUTOMATED
Product CodeKPA
Date Received2019-09-13
Model NumberNA
Catalog Number06917259001
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS INC
Manufacturer Address1910 E INNOVATION PARK DR NA TUCSON AZ 85755 US 85755


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-13

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