• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PROMARK ENDODONTIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTSPLY TULSA DENTAL SPECIALTIES PROMARK ENDODONTIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number PMKEM1
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Shock (2072); Electric Shock (2554)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported that a patient felt an electrical shock during use of a promark endo motor; no intervention was required.
 
Manufacturer Narrative
The device was evaluated and found to be within specification.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMARK ENDODONTIC MOTOR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
608 rolling hills drive
johnson city TN 37604
Manufacturer (Section G)
ASEPTICO, INC
8333 216th st se
woodinville WA 98072
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7426245
MDR Text Key105531587
Report Number2320721-2018-00018
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMKEM1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-