ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET2CT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET2CT manufactured by Braun Gmbh Werk Marktheidenfeld.

MAUDE Entry Details

Report Number3000302531-2020-00048
MDR Report Key9834483
Report SourceCONSUMER
Date Received2020-03-16
Date of Report2020-02-20
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMGR. REGULATORY ORAL CARE
Manufacturer Street8700 MASON-MONTGOMERY RD
Manufacturer CityMASON, OH
Manufacturer CountryUS
Manufacturer G1BRAUN GMBH WERK MARKTHEIDENFELD
Manufacturer Street40 BAUMHOFSTRASSE
Manufacturer CityMARKTHEIDENFELD, D-97828
Manufacturer CountryGM
Manufacturer Postal CodeD-97828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET2CT
Generic NameTOOTHBRUSH, POWERED
Product CodeJEQ
Date Received2020-03-16
Model NumberEB20
Lot NumberNOT AVAILABLE
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBRAUN GMBH WERK MARKTHEIDENFELD
Manufacturer Address40 BAUMHOFSTRASSE MARKTHEIDENFELD, D-97828 GM D-97828


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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