PROTAPER UNIVERSAL ROTARY FILE S1 21MM PTURS121

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for PROTAPER UNIVERSAL ROTARY FILE S1 21MM PTURS121 manufactured by Tulsa Dental Products Llc.

MAUDE Entry Details

Report Number2320721-2020-00024
MDR Report Key9819592
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-11
Date of Report2020-03-06
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. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK, PA
Manufacturer CountryUS
Manufacturer Phone8494229
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROTAPER UNIVERSAL ROTARY FILE S1 21MM
Generic NameFILE, PULP CANAL, ENDODONTIC
Product CodeEKS
Date Received2020-03-11
Returned To Mfg2020-02-14
Model NumberNA
Catalog NumberPTURS121
Lot Number1614031
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTULSA DENTAL PRODUCTS LLC
Manufacturer Address608 ROLLING HILLS DRIVE JOHNSON CITY, TN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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