NUCLISENS? EXTRACTION BUFFER 3 280132

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 2019-09-27 for NUCLISENS? EXTRACTION BUFFER 3 280132 manufactured by Biomerieux, Sa.

MAUDE Entry Details

Report Number3008249922-2019-00003
MDR Report Key9132234
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-09-27
Date of Report2019-09-27
Date Mfgr Received2019-08-28
Device Manufacturer Date2018-12-21
Date Added to Maude2019-09-27
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 ContactMR. MATTHEW LOCUS
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street5 RUE DES BERGES
Manufacturer City38024 GRENOBLE,
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLISENS? EXTRACTION BUFFER 3
Generic NameNUCL. EXTR. BUFFER 3(4X1L)
Product CodeLTD
Date Received2019-09-27
Catalog Number280132
Lot NumberZ010BE3EB
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address5 RUE DES BERGES 38024 GRENOBLE, FR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-27

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