ALINITY I TOTAL B-HCG 07P51-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-04 for ALINITY I TOTAL B-HCG 07P51-20 manufactured by A.i.d.d Longford.

MAUDE Entry Details

Report Number3005094123-2020-00032
MDR Report Key9666977
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-04
Date of Report2020-02-04
Date of Event2020-01-16
Date Mfgr Received2020-01-16
Device Manufacturer Date2019-09-13
Date Added to Maude2020-02-04
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 ContactCHRISTIAN LEE
Manufacturer Street100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224668-294
Manufacturer G1A.I.D.D LONGFORD
Manufacturer StreetLISNAMUCK CO. LONGFORD
Manufacturer CityLONGFORD NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALINITY I TOTAL B-HCG
Generic NameB-HCG
Product CodeDHA
Date Received2020-02-04
Catalog Number07P51-20
Lot Number06112UI00
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerA.I.D.D LONGFORD
Manufacturer AddressLISNAMUCK CO. LONGFORD LONGFORD NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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