GAMMACLONE ANTI-D (MONOCLONAL BLEND) 0066420

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 2019-05-20 for GAMMACLONE ANTI-D (MONOCLONAL BLEND) 0066420 manufactured by Immucor, Inc..

MAUDE Entry Details

Report Number1034569-2019-00099
MDR Report Key8625324
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-20
Date of Report2019-05-20
Date of Event2019-05-07
Date Mfgr Received2019-05-07
Date Added to Maude2019-05-20
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 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 NameGAMMACLONE ANTI-D (MONOCLONAL BLEND)
Generic NameBLOOD GROUPING REAGENT
Product CodeKSF
Date Received2019-05-20
Catalog Number0066420
Lot Number506270
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 2019-05-20

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