MO.MA ULTRA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-28 for MO.MA ULTRA manufactured by Invatec Spa.

MAUDE Entry Details

Report Number3004066202-2020-00007
MDR Report Key9768396
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-01-01
Date Mfgr Received2020-02-18
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 Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Manufacturer Phone091708734
Manufacturer G1INVATEC SPA
Manufacturer StreetVIA MARTIRI DELLA LIBERTA, 7
Manufacturer CityRONCADELLE 25030
Manufacturer CountryIT
Manufacturer Postal Code25030
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMO.MA ULTRA
Generic NameCATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
Product CodeNTE
Date Received2020-02-28
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINVATEC SPA
Manufacturer AddressVIA MARTIRI DELLA LIBERTA, 7 RONCADELLE 25030 IT 25030


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-28

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