PEESO-ENLARGERS C.A. V010183019001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for PEESO-ENLARGERS C.A. V010183019001 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[126087133] There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event 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


[126087134] In this event it was reported that a pesso enlarger was broken. The broken part was removed and the canal filled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2018-00175
MDR Report Key8035612
Date Received2018-11-02
Date of Report2018-12-12
Date Mfgr Received2018-12-10
Date Added to Maude2018-11-02
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 MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePEESO-ENLARGERS C.A.
Generic NameREAMER, PULP CANAL, ENDODONTIC
Product CodeEKP
Date Received2018-11-02
Model NumberNA
Catalog NumberV010183019001
Lot NumberUNK
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 2018-11-02

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