INNOVANCE PFA-200 SYSTEM 10488536

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 2019-05-03 for INNOVANCE PFA-200 SYSTEM 10488536 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

MAUDE Entry Details

Report Number9610806-2019-00047
MDR Report Key8577793
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-05-03
Date of Report2019-05-03
Date of Event2019-04-03
Date Mfgr Received2019-04-12
Date Added to Maude2019-05-03
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. BENLEY SAINT-JEAN
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242398
Manufacturer G1BIT ANALYTICAL INSTRUMENTS GMBH
Manufacturer StreetREGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3
Manufacturer CitySCHWALBACH, 65824
Manufacturer CountryGM
Manufacturer Postal Code65824
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINNOVANCE PFA-200 SYSTEM
Generic NameINNOVANCE PFA-200 SYSTEM
Product CodeJOZ
Date Received2019-05-03
Model NumberINNOVANCE PFA-200 SYSTEM
Catalog Number10488536
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-03

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