VIDAS D-DIMER EXCLUSION II 60T 30455-02

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 2020-02-06 for VIDAS D-DIMER EXCLUSION II 60T 30455-02 manufactured by Biomerieux Sa.

MAUDE Entry Details

Report Number8020790-2020-00014
MDR Report Key9678425
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-06
Date of Report2020-03-27
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-07-25
Date Added to Maude2020-02-06
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 ContactCANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, SA
Manufacturer StreetCHEMIN DE L ORME
Manufacturer CityMACRY L ETOILE 69280
Manufacturer CountryFR
Manufacturer Postal Code69280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIDAS D-DIMER EXCLUSION II 60T
Generic NameVIDAS D-DIMER EXCLUSION II 60T
Product CodeDAP
Date Received2020-02-06
Catalog Number30455-02
Lot Number1007479470
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 69280 FR 69280


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-06

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