ETEST? MEROEPENEM 513800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-28 for ETEST? MEROEPENEM 513800 manufactured by Biomerieux Sa.

MAUDE Entry Details

Report Number9615754-2020-00037
MDR Report Key9771746
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-02-28
Date of Report2020-02-28
Date Mfgr Received2020-01-30
Date Added to Maude2020-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactCANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
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 NameETEST? MEROEPENEM
Generic NameETEST? MEROPENEM
Product CodeJWY
Date Received2020-02-28
Catalog Number513800
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 2020-02-28

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