VIDAS? ANALYSER - 99735

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 2020-01-13 for VIDAS? ANALYSER - 99735 manufactured by Biomerieux Italia S.p.a..

MAUDE Entry Details

Report Number9615037-2020-00003
MDR Report Key9582274
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-13
Date of Report2020-02-25
Date Mfgr Received2020-01-27
Date Added to Maude2020-01-13
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 ITALIA S.P.A.
Manufacturer StreetVIA DI CAMPIGLIANO 58 / LOC. P
Manufacturer CityFIRENZE
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS? ANALYSER - 99735
Generic NameVIDAS? ANALYSER - 99735
Product CodeDEW
Date Received2020-01-13
Model Number99735
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX ITALIA S.P.A.
Manufacturer AddressVIA DI CAMPIGLIANO 58 / LOC. P FIRENZE 50012 IT 50012


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.