INVIVODENTAL/TXSTUDIO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-28 for INVIVODENTAL/TXSTUDIO manufactured by Anatomage Inc..

MAUDE Entry Details

Report Number3008272529-2019-00016
MDR Report Key8942471
Report SourceHEALTH PROFESSIONAL
Date Received2019-08-28
Date of Report2019-08-26
Date of Event2019-02-15
Date Mfgr Received2019-02-22
Device Manufacturer Date2014-03-12
Date Added to Maude2019-08-28
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 ContactMEERA KLER
Manufacturer Street303 ALMADEN BLVD. SUITE 700
Manufacturer CitySAN JOSE CA 95110
Manufacturer CountryUS
Manufacturer Postal95110
Manufacturer G1ANATOMAGE INC.
Manufacturer Street303 ALMADEN BLVD. SUITE 700
Manufacturer CitySAN JOSE CA 95110
Manufacturer CountryUS
Manufacturer Postal Code95110
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVIVODENTAL/TXSTUDIO
Generic NameSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Product CodeLLZ
Date Received2019-08-28
Lot Number5.3
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerANATOMAGE INC.
Manufacturer Address303 ALMADEN BLVD. SUITE 700 SAN JOSE CA 95110 US 95110


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-28

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