ETEST? BENZYLPENICIL PG 32 US F100 502658

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-27 for ETEST? BENZYLPENICIL PG 32 US F100 502658 manufactured by Biomerieux Sa.

MAUDE Entry Details

Report Number9615754-2020-00054
MDR Report Key9888194
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-27
Date of Report2020-03-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-07-18
Date Added to Maude2020-03-27
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 Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME
Manufacturer CountryFR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETEST? BENZYLPENICIL PG 32 US F100
Generic NameBENZYLPENICIL PG 32 US F100 - 502658
Product CodeJWY
Date Received2020-03-27
Catalog Number502658
Lot Number1007477190
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 FR


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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