PREVI? COLOR GRAM (VERSION2) 414292

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 2019-12-06 for PREVI? COLOR GRAM (VERSION2) 414292 manufactured by Biom?rieux Sa.

MAUDE Entry Details

Report Number8020790-2019-00073
MDR Report Key9434273
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-12-06
Date of Report2020-02-27
Date Mfgr Received2020-01-31
Date Added to Maude2019-12-06
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 ContactMS. JENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX SA
Manufacturer Street376 CHEMIN DE L'ORME
Manufacturer CityMARCY L ETOILE 69280
Manufacturer CountryFR
Manufacturer Postal Code69280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREVI? COLOR GRAM (VERSION2)
Generic NamePREVI COLOR GRAM INSTRUMENT V2 - 414292
Product CodeKPA
Date Received2019-12-06
Model Number414292
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOM?RIEUX SA
Manufacturer Address376 CHEMIN DE L'ORME MARCY L'ETOILE 69280 FR 69280


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-06

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