TOMTEC-ARENA TTA2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-15 for TOMTEC-ARENA TTA2 manufactured by Tomtec Imaging Systems Gmbh.

MAUDE Entry Details

Report Number8043836-2019-00003
MDR Report Key9328104
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-15
Date of Report2019-11-15
Date of Event2019-10-16
Date Mfgr Received2019-10-16
Date Added to Maude2019-11-15
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 ContactMR. HANS BEINKE
Manufacturer StreetEDISONSTRASSE 6
Manufacturer CityUNTERSCHLEISSHEIM, 85764
Manufacturer CountryGM
Manufacturer Postal85764
Manufacturer G1TOMTEC IMAGING SYSTEMS GMBH
Manufacturer StreetEDISONSTRASSE 6
Manufacturer CityUNTERSCHLEISSHEIM, 85764
Manufacturer CountryGM
Manufacturer Postal Code85764
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOMTEC-ARENA TTA2
Generic NameIMAGE REVIEW AND QUANTIFICATION SOFTWARE
Product CodeLLZ
Date Received2019-11-15
Model NumberTTA2
Lot Number31.00
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTOMTEC IMAGING SYSTEMS GMBH
Manufacturer AddressEDISONSTRASSE 6 UNTERSCHLEISSHEIM, 85764 GM 85764


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-15

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