BACT/ALERT? FA PLUS 410851

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-08-29 for BACT/ALERT? FA PLUS 410851 manufactured by Biomerieux Inc..

MAUDE Entry Details

Report Number3002769706-2019-00056
MDR Report Key8947129
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-08-29
Date of Report2019-08-29
Date Mfgr Received2019-07-31
Device Manufacturer Date2019-01-28
Date Added to Maude2019-08-29
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 ContactMS. JENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX INC.
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal Code27712
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBACT/ALERT? FA PLUS
Generic NameBACT/ALERT? FA PLUS
Product CodeMDB
Date Received2019-08-29
Catalog Number410851
Lot Number4052897
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX INC.
Manufacturer Address100 RODOLPHE STREET DURHAM NC 27712 US 27712


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-29

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