CHROMID? CANDIDA AGAR 43631

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 2019-08-30 for CHROMID? CANDIDA AGAR 43631 manufactured by Biomerieux S.a..

MAUDE Entry Details

Report Number9615755-2019-00006
MDR Report Key8952299
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-08-30
Date of Report2019-08-30
Date Mfgr Received2019-08-05
Device Manufacturer Date2019-01-27
Date Added to Maude2019-08-30
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 S.A.
Manufacturer Street5 RUE DES AQUEDUCS
Manufacturer CityCRAPONNE, 69290
Manufacturer CountryFR
Manufacturer Postal Code69290
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHROMID? CANDIDA AGAR
Generic NameCHROMID? CANDIDA AGAR
Product CodeJSJ
Date Received2019-08-30
Catalog Number43631
Lot Number1007436560
Device Expiration Date2019-10-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX S.A.
Manufacturer Address5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-30

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