CONE BEAM 3D IMAGE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for CONE BEAM 3D IMAGE UNKNOWN manufactured by Unknown.

MAUDE Entry Details

Report NumberMW5089055
MDR Report Key8894721
Date Received2019-08-13
Date of Report2019-08-12
Date of Event2019-08-09
Date Added to Maude2019-08-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCONE BEAM 3D IMAGE
Generic NameSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL
Product CodeMUH
Date Received2019-08-13
Model NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-08-13

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