GUTTAFUSION OBTURATOR OVEN V041500000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for GUTTAFUSION OBTURATOR OVEN V041500000000 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[123209879] While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[123209880] In this event it was reported that a gutta fusion oven, when removing it from the socket only, happened to cause an electric shock; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2018-00149
MDR Report Key7940272
Date Received2018-10-05
Date of Report2018-12-04
Date Mfgr Received2018-11-12
Date Added to Maude2018-10-05
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 G1UNITRON GROUP BV
Manufacturer StreetSCHANSESTRAAT 7
Manufacturer CityIJZENDIJKE ZEELAND, 4515
Manufacturer CountryNL
Manufacturer Postal Code4515
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGUTTAFUSION OBTURATOR OVEN
Generic NameGUTTA-PERCHA
Product CodeEKM
Date Received2018-10-05
Model NumberNA
Catalog NumberV041500000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2018-10-05

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