EDDY IRRIGATION TIP V041441000000

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 2020-02-21 for EDDY IRRIGATION TIP V041441000000 manufactured by Dentsply Vdw Gmbh.

MAUDE Entry Details

Report Number9611053-2020-00032
MDR Report Key9742539
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-21
Date of Report2020-03-30
Date Mfgr Received2020-01-22
Date Added to Maude2020-02-21
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 Phone8494424
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 NameEDDY IRRIGATION TIP
Generic NameSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Product CodeEIC
Date Received2020-02-21
Returned To Mfg2020-02-10
Model NumberNA
Catalog NumberV041441000000
Lot Number300412
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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