CONTROL MODULE PKGD 3D - 210147

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 2020-01-15 for CONTROL MODULE PKGD 3D - 210147 manufactured by Biomerieux, Inc..

MAUDE Entry Details

Report Number1950204-2020-00007
MDR Report Key9593570
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-01-15
Date of Report2020-01-15
Date Mfgr Received2019-12-16
Date Added to Maude2020-01-15
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 ContactJENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTROL MODULE PKGD 3D - 210147
Generic NameCONTROL MODULE PKGD 3D - 210147
Product CodeMDB
Date Received2020-01-15
Model Number210147
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15

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