MASTERMATIC LUX M05 L 1.009.3640

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-18 for MASTERMATIC LUX M05 L 1.009.3640 manufactured by Kavo Dental Gmbh.

MAUDE Entry Details

Report Number3003637274-2020-00005
MDR Report Key9719195
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-18
Date of Report2020-01-17
Date of Event2020-01-13
Date Mfgr Received2020-01-22
Device Manufacturer Date2019-07-25
Date Added to Maude2020-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KLAUS REISENAUER
Manufacturer StreetBISMARCKRING 39
Manufacturer CityBIBERACH / RISS, 88400
Manufacturer CountryGM
Manufacturer Postal88400
Manufacturer G1KAVO DENTAL GMBH
Manufacturer StreetBISMARCKRING 39
Manufacturer CityBIBERACH / RISS, 88400
Manufacturer CountryGM
Manufacturer Postal Code88400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMASTERMATIC LUX M05 L
Generic NameDENTAL ELECTRICAL HANDPIECE
Product CodeEGS
Date Received2020-02-18
Model NumberM05 L
Catalog Number1.009.3640
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKAVO DENTAL GMBH
Manufacturer AddressBISMARCKRING 39 BIBERACH / RISS, 88400 GM 88400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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