ATELLICA IM TOXOPLASMA IGG (TOXO G) N/A 10995699

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 2020-02-06 for ATELLICA IM TOXOPLASMA IGG (TOXO G) N/A 10995699 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

Report Number1219913-2020-00034
MDR Report Key9678496
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-06
Date of Report2020-03-05
Date of Event2019-07-27
Date Mfgr Received2020-02-11
Device Manufacturer Date2019-08-09
Date Added to Maude2020-02-06
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. STEPHEN PERRY
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal02032
Manufacturer Phone5086604163
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal Code02032
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATELLICA IM TOXOPLASMA IGG (TOXO G)
Generic NameTOXOPLASMA GONDII IMMUNOASSAY
Product CodeLGD
Date Received2020-02-06
Model NumberN/A
Catalog Number10995699
Lot Number42017252
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-02-06

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