GX-770 0.820.0146

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-23 for GX-770 0.820.0146 manufactured by Gendex Dental Systems.

MAUDE Entry Details

Report Number2530069-2019-00006
MDR Report Key9226657
Report SourceUSER FACILITY
Date Received2019-10-23
Date of Report2019-10-23
Date of Event2019-05-14
Date Mfgr Received2019-05-20
Device Manufacturer Date1989-01-01
Date Added to Maude2019-10-23
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. AL MYERS
Manufacturer Street1910 NORTH PENN ROAD
Manufacturer CityHATFIELD PA 19440
Manufacturer CountryUS
Manufacturer Postal19440
Manufacturer Phone2159975665
Manufacturer G1GENDEX DENTAL SYSTEMS
Manufacturer Street1910 NORTH PENN ROAD
Manufacturer CityHATFIELD PA 19440
Manufacturer CountryUS
Manufacturer Postal Code19440
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGX-770
Generic NameUNIT, X-RAY EXTRAORAL WITH TIMER
Product CodeEHD
Date Received2019-10-23
Model NumberGX-770
Catalog Number0.820.0146
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGENDEX DENTAL SYSTEMS
Manufacturer Address1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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