TOMTEC-ARENA TT2 TTA2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for TOMTEC-ARENA TT2 TTA2 manufactured by Tomtec Imaging Systems Gmbh.

MAUDE Entry Details

Report Number8043836-2019-00002
MDR Report Key9087767
Date Received2019-09-19
Date of Report2019-11-12
Date of Event2016-06-14
Date Added to Maude2019-09-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Removal Correction Number8043836-10/02/19-001-C
Event Type3
Type of Report3

Device Details

Brand NameTOMTEC-ARENA TT2
Generic NameIMAGE REVIEW AND QUANTIFICATION SOFTWARE
Product CodeLLZ
Date Received2019-09-19
Model NumberTTA2
Lot Number11.01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTOMTEC IMAGING SYSTEMS GMBH
Manufacturer AddressEDISONSTRASSE 6 UNTERSCHLEISSHEIM, 85764 GM 85764


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-19

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