I-STAT EG7+ CARTRIDGE 03P76-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-08 for I-STAT EG7+ CARTRIDGE 03P76-25 manufactured by Abbott Point Of Care.

MAUDE Entry Details

Report Number2245578-2020-00007
MDR Report Key9563935
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-08
Date of Report2020-01-29
Date of Event2020-01-01
Date Mfgr Received2020-01-23
Device Manufacturer Date2019-12-11
Date Added to Maude2020-01-08
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 ContactLINDA MACZUSZENKO
Manufacturer Street400 COLLEGE ROAD
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6136885949
Manufacturer G1ABBOTT POINT OF CARE CANADA LTD.
Manufacturer Street185 CORKSTOWN ROAD
Manufacturer CityK2H 8V4
Manufacturer CountryCA
Manufacturer Postal CodeK2H 8V4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-STAT EG7+ CARTRIDGE
Generic NameEG7+ CARTRIDGE
Product CodeCHL
Date Received2020-01-08
Model NumberNA
Catalog Number03P76-25
Lot NumberW19345
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-08

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