DADE INNOVIN 10873567

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 2020-03-31 for DADE INNOVIN 10873567 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

MAUDE Entry Details

Report Number9610806-2020-00010
MDR Report Key9904389
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
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 ContactCHRISTOPHER AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN, NY
Manufacturer CountryUS
Manufacturer Phone5242740
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL-VON-BEHRING-STR. 76
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDADE INNOVIN
Generic NameDADE INNOVIN
Product CodeGJS
Date Received2020-03-31
Model NumberDADE INNOVIN
Catalog Number10873567
Lot Number549758
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 2020-03-31

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