JELTRATE DUSTLESS 689310

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-14 for JELTRATE DUSTLESS 689310 manufactured by Dentsply Caulk.

MAUDE Entry Details

Report Number2515379-2019-00020
MDR Report Key8700801
Report SourceDISTRIBUTOR
Date Received2019-06-14
Date of Report2019-07-11
Date Mfgr Received2019-06-17
Date Added to Maude2019-06-14
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 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 W. CLARK AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJELTRATE DUSTLESS
Generic NameMATERIAL, IMPRESSION
Product CodeELW
Date Received2019-06-14
Returned To Mfg2019-06-04
Model NumberNA
Catalog Number689310
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer Address38 W. CLARK AVE. MILFORD DE 19963 US 19963


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-14

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