CONFIRM ANTI-MSH6 (44) MOUSE MONO 05929911001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-19 for CONFIRM ANTI-MSH6 (44) MOUSE MONO 05929911001 manufactured by Ventana Medical Systems.

MAUDE Entry Details

Report Number2028492-2019-00012
MDR Report Key8713836
Date Received2019-06-19
Date of Report2019-07-08
Date of Event2019-05-20
Date Mfgr Received2019-05-20
Date Added to Maude2019-06-19
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
Manufacturer CityNA
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameCONFIRM ANTI-MSH6 (44) MOUSE MONO
Generic NameLYNCH SYNDROME TEST SYSTEM
Product CodePZJ
Date Received2019-06-19
Model NumberNA
Catalog Number05929911001
Lot NumberE10710
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS
Manufacturer Address1910 E. INNOVATION PARK DR. NA TUCSON AZ 85755 US 85755


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-19

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