DIMENSION? 10444889 RF451 SMN 10444889

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-31 for DIMENSION? 10444889 RF451 SMN 10444889 manufactured by Siemens Healthcare Diagnostics Inc.

MAUDE Entry Details

Report Number2517506-2020-00032
MDR Report Key9652921
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-31
Date of Report2020-01-31
Date of Event2019-12-18
Date Mfgr Received2020-01-16
Device Manufacturer Date2019-08-27
Date Added to Maude2020-01-31
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 ContactJAMES MORGERA
Manufacturer Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal197146101
Manufacturer Phone3026318356
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Street500 GBC DRIVE PO BOX 6101
Manufacturer CityNEWARK DE 197146101
Manufacturer CountryUS
Manufacturer Postal Code197146101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIMENSION?
Generic NameDIMENSION? TPSA TOTAL PROSTATE SPECIFIC ANTIGEN FLEX? REAGENT CARTRIDGE
Product CodeMTF
Date Received2020-01-31
Model Number10444889
Catalog NumberRF451 SMN 10444889
Lot NumberEF0240
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC
Manufacturer Address500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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