EMAG? INSTRUMENT 418591

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-14 for EMAG? INSTRUMENT 418591 manufactured by Biomerieux Italia S.p.a..

MAUDE Entry Details

Report Number9615037-2019-00014
MDR Report Key8893576
Date Received2019-08-14
Date of Report2019-11-07
Date Mfgr Received2019-10-10
Date Added to Maude2019-08-14
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 ITALIA S.P.A.
Manufacturer StreetVIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI
Manufacturer CityFIRENZE,
Manufacturer CountryIT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMAG? INSTRUMENT
Generic NameEMAG? INSTRUMENT
Product CodeJJH
Date Received2019-08-14
Model Number418591
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX ITALIA S.P.A.
Manufacturer AddressVIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI FIRENZE, IT


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-14

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