ANTI-LEB MURINE MONOCLONAL 0004864

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 2020-01-30 for ANTI-LEB MURINE MONOCLONAL 0004864 manufactured by Immucor, Inc..

MAUDE Entry Details

Report Number1034569-2020-00006
MDR Report Key9647926
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-30
Date of Report2020-01-30
Date Added to Maude2020-01-30
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 NameANTI-LEB MURINE MONOCLONAL
Generic NameREAGENT RED BLOOD CELLS
Product CodeQHT
Date Received2020-01-30
Catalog Number0004864
Lot Number992018
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 2020-01-30

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