VIDAS? BRAHAMS PROCALCITONIN 30450-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-04 for VIDAS? BRAHAMS PROCALCITONIN 30450-01 manufactured by Biomerieux Sa.

MAUDE Entry Details

Report Number8020790-2019-00031
MDR Report Key8669246
Date Received2019-06-04
Date of Report2019-09-09
Date Mfgr Received2019-08-14
Device Manufacturer Date2018-12-05
Date Added to Maude2019-06-04
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. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX SA
Manufacturer StreetCHEMIN DE L ORME
Manufacturer CityMARCY L ETOILE, RHONE 69280,
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVIDAS? BRAHAMS PROCALCITONIN
Generic NameVIDAS? BRAHAMS PCT
Product CodePRI
Date Received2019-06-04
Catalog Number30450-01
Lot Number1006974220
Device Expiration Date2019-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer AddressCHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-04

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