ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) N/A 10995544

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 2019-10-01 for ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) N/A 10995544 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

Report Number1219913-2019-00201
MDR Report Key9140656
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-10-01
Date of Report2019-10-01
Date of Event2019-09-07
Date Mfgr Received2019-09-12
Date Added to Maude2019-10-01
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. EIMAN SULIEMAN
Manufacturer Street333 CONEY STREET
Manufacturer CityE. WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal02032
Manufacturer Phone5086604603
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityWALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal Code02032
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA)
Generic NameCPSA IMMUNOASSAY
Product CodeNAF
Date Received2019-10-01
Model NumberN/A
Catalog Number10995544
Lot Number285
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-01

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