BACT/ALERT? SA CULTURE BOTTLE 259789

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-16 for BACT/ALERT? SA CULTURE BOTTLE 259789 manufactured by Biomerieux Inc..

MAUDE Entry Details

Report Number3002769706-2019-00040
MDR Report Key8903707
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-08-16
Date of Report2019-10-11
Date Mfgr Received2019-10-04
Device Manufacturer Date2018-10-08
Date Added to Maude2019-08-16
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. CANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
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? SA CULTURE BOTTLE
Generic NameBACT/ALERT? SA CULTURE BOTTLE
Product CodeMDB
Date Received2019-08-16
Catalog Number259789
Lot Number1052142
Device Expiration Date2019-10-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
101. Required No Informationntervention 2019-08-16

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