PROMARK ENDODONTIC MOTOR PMKEM1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for PROMARK ENDODONTIC MOTOR PMKEM1 manufactured by Tulsa Dental Products Llc.

Event Text Entries

[184460364] There has been a previous report received where this malfunction has caused file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr 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


[184460365] In this event it was reported that a promark foot pedal was causing the unit to run constantly. No injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320721-2019-00293
MDR Report Key9578853
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-10
Date of Report2020-03-04
Date Mfgr Received2019-12-11
Date Added to Maude2020-01-10
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 G1ASEPTICO, INC
Manufacturer Street8333 216TH ST SE
Manufacturer CityWOODINVILLE WA 98072
Manufacturer CountryUS
Manufacturer Postal Code98072
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROMARK ENDODONTIC MOTOR
Generic NameHANDPIECE, DIRECT DRIVE, AC-POWERED
Product CodeEKX
Date Received2020-01-10
Model NumberNA
Catalog NumberPMKEM1
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTULSA DENTAL PRODUCTS LLC
Manufacturer Address608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.