ABBOTT PRISM CHAGAS 07K35-68

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 2019-11-25 for ABBOTT PRISM CHAGAS 07K35-68 manufactured by Abbott Laboratories.

MAUDE Entry Details

Report Number1415939-2019-00221
MDR Report Key9369294
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-25
Date of Report2019-11-25
Date Mfgr Received2019-11-14
Date Added to Maude2019-11-25
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 G1ABBOTT LABORATORIES
Manufacturer Street100 ABBOTT PARK ROAD
Manufacturer CityABBOTT PARK IL 600643500
Manufacturer CountryUS
Manufacturer Postal Code600643500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABBOTT PRISM CHAGAS
Generic NameCHAGAS
Product CodeMIU
Date Received2019-11-25
Catalog Number07K35-68
Lot Number05069M700
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-25

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