AH TEMP 606.20.123

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-26 for AH TEMP 606.20.123 manufactured by Dentsply Detrey Gmbh.

MAUDE Entry Details

Report Number8010638-2019-00008
MDR Report Key8736161
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-06-26
Date of Report2019-06-25
Date Mfgr Received2019-05-27
Date Added to Maude2019-06-26
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 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1DENTSPLY DETREY GMBH
Manufacturer StreetDETREY STRASSE 1
Manufacturer CityKONSTANZ, 78467
Manufacturer CountryGM
Manufacturer Postal Code78467
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAH TEMP
Generic NameAGENT, TOOTH BONDING, RESIN
Product CodeKLE
Date Received2019-06-26
Model NumberNA
Catalog Number606.20.123
Lot Number1606000805
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY DETREY GMBH
Manufacturer AddressDETREY STRASSE 1 KONSTANZ, 78467 GM 78467


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-26

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