CERETOM NL3000

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 2020-02-21 for CERETOM NL3000 manufactured by Neurologica Corporation.

MAUDE Entry Details

Report Number3004938766-2020-00002
MDR Report Key9742475
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-21
Date of Report2020-02-21
Date of Event2020-01-21
Date Mfgr Received2020-01-21
Device Manufacturer Date2015-11-30
Date Added to Maude2020-02-21
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 ContactDR. NINAD GUJAR
Manufacturer Street14 ELECTRONICS AVENUE
Manufacturer CityDANVERS, MA
Manufacturer CountryUS
Manufacturer Phone5648632
Manufacturer G1NEUROLOGICA CORPORATION
Manufacturer Street14 ELECTRONICS AVENUE
Manufacturer CityDANVERS, MA
Manufacturer CountryUS
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERETOM
Generic NameCOMPUTED TOMOGRAPHY X-RAY SYSTEM
Product CodeJAK
Date Received2020-02-21
Model NumberNL3000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNEUROLOGICA CORPORATION
Manufacturer Address14 ELECTRONICS AVENUE DANVERS, MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.