K-REAMERS, CC+, STERILE V040353025010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-27 for K-REAMERS, CC+, STERILE V040353025010 manufactured by Dentsply Vdw Gmbh.

MAUDE Entry Details

Report Number9611053-2020-00023
MDR Report Key9764955
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-02-27
Date of Report2020-02-14
Date Added to Maude2020-02-27
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 ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK, PA
Manufacturer CountryUS
Manufacturer Phone8494229
Manufacturer G1DENTSPLY VDW GMBH
Manufacturer StreetBAYERWALDSTRASSE 15
Manufacturer CityMUNICH, 81737
Manufacturer CountryGM
Manufacturer Postal Code81737
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameK-REAMERS, CC+, STERILE
Generic NameFILE, PULP CANAL, ENDODONTIC
Product CodeEKS
Date Received2020-02-27
Returned To Mfg2020-01-17
Model NumberNA
Catalog NumberV040353025010
Lot Number261286
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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