NOMAD PRO 0.850.0009

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 2020-03-11 for NOMAD PRO 0.850.0009 manufactured by Airbex.

MAUDE Entry Details

Report Number1017522-2020-00003
MDR Report Key9820640
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-02-09
Date Mfgr Received2020-02-11
Device Manufacturer Date2009-06-01
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVID WATERS
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE, NC
Manufacturer CountryUS
Manufacturer Phone5877297
Manufacturer G1AIRBEX
Manufacturer Street11727 FRUEHAUF DRIVE
Manufacturer CityCHARLOTTE, NC
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOMAD PRO
Generic NameEXTRAORAL SOURCE X-RAY SYSTEM
Product CodeEHD
Date Received2020-03-11
Returned To Mfg2020-02-28
Model Number0.850.0009
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAIRBEX
Manufacturer Address11727 FRUEHAUF DRIVE CHARLOTTE, NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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