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

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL

  • 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 PROFESSIONAL MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875205
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Type  malfunction  
Manufacturer Narrative
Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
 
Event Description
In this event a doctor reported that a midwest e plus 1:5 attachment overheated and burned a patient's cheek. The doctor applied vitamin e oil to the burn.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer (Section G)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, hessen D-646 25
GM D-64625
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key6947968
MDR Text Key90204615
Report Number1419322-2017-00251
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 10/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number875205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-