ABBOTT PRISM HIV O PLUS 03L68-68

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 2019-11-06 for ABBOTT PRISM HIV O PLUS 03L68-68 manufactured by Abbott Laboratories.

MAUDE Entry Details

Report Number1415939-2019-00217
MDR Report Key9285679
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-06
Date of Report2019-11-18
Date of Event2019-10-09
Date Mfgr Received2019-11-14
Device Manufacturer Date2018-11-01
Date Added to Maude2019-11-06
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 HIV O PLUS
Generic NameHIV-1 AND HIV-2 ANTIBODIES
Product CodeMZF
Date Received2019-11-06
Catalog Number03L68-68
Lot Number02010N100
Device Expiration Date2019-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT LABORATORIES
Manufacturer Address100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US 600643500


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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