ETEST? BENZYLPENICILLIN PG 32 WW F100 502618

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 2019-08-09 for ETEST? BENZYLPENICILLIN PG 32 WW F100 502618 manufactured by Biomerieux Sa.

MAUDE Entry Details

Report Number9615754-2019-00057
MDR Report Key8880346
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-08-09
Date of Report2019-11-22
Date Mfgr Received2019-10-30
Device Manufacturer Date2018-10-08
Date Added to Maude2019-08-09
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 ContactMS. JENNIFER 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 NameETEST? BENZYLPENICILLIN PG 32 WW F100
Generic NameETEST? BENZYLPENICILLIN
Product CodeJWY
Date Received2019-08-09
Catalog Number502618
Lot Number1006836110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383, FR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-09

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