Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 TRADITION FIBER OPTIC HS HANDPIECE; AIR-POWERED DENTAL HANDPIECE
  • 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 TRADITION FIBER OPTIC HS HANDPIECE; AIR-POWERED DENTAL HANDPIECE Back to Search Results
Catalog Number 750045
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
In this event it was reported that cap unscrewed from a tradition handpiece while in use.The reported complaint did not result in an injury or need for intervention.
 
Manufacturer Narrative
Though no medical/surgical intervention was required to preclude a serious injury in this event, there has been a previously reported event 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.Production and quality testing could not be performed because the device was not returned in working condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRADITION FIBER OPTIC HS HANDPIECE
Type of Device
AIR-POWERED DENTAL HANDPIECE
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
des plaines IL
Manufacturer Contact
helen lewis
221 w. philadelphia st., ste. 60
susquehanna commerce center w.
york, PA 17401
7178457511
MDR Report Key4250265
MDR Text Key17993815
Report Number1419322-2014-00074
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K863677
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 10/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number750045
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/08/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-