API? LISTERIA 10STRIPS+10MEDIA 10300

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 2020-03-26 for API? LISTERIA 10STRIPS+10MEDIA 10300 manufactured by Biomerieux, Sa.

MAUDE Entry Details

Report Number9615754-2020-00051
MDR Report Key9885484
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-09-17
Date Added to Maude2020-03-26
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 ContactJENNIFER ARMSTRONG
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145068201
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME 38390
Manufacturer CountryFR
Manufacturer Postal Code38390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPI? LISTERIA 10STRIPS+10MEDIA
Generic NameAPI? LISTERIA 10STRIPS+10MEDIA
Product CodeJTO
Date Received2020-03-26
Catalog Number10300
Lot Number1007599020
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME 38390 FR 38390


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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