ECHO 0087000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-29 for ECHO 0087000 manufactured by Immucor, Inc..

MAUDE Entry Details

Report Number1034569-2020-00008
MDR Report Key9644960
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-29
Date of Report2020-01-29
Date Added to Maude2020-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR HOWARD YOREK
Manufacturer Street3130 GATEWAY DRIVE
Manufacturer CityNORCROSS GA 300915625
Manufacturer CountryUS
Manufacturer Postal300915625
Manufacturer Phone7704412051
Manufacturer G1IMMUCOR, INC.
Manufacturer Street3130 GATEWAY DRIVE
Manufacturer CityNORCROSS GA 300915625
Manufacturer CountryUS
Manufacturer Postal Code300915625
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECHO
Generic NameAUTOMATED BLOOD BANK SYSTEM
Product CodeKSZ
Date Received2020-01-29
Model Number0087000
Catalog Number0087000
Lot NumberR094,39351,504846
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIMMUCOR, INC.
Manufacturer Address3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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