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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS PLUS SPM HANDPIECE, AIR-POWERED, DENTAL

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DENTSPLY PROFESSIONAL MIDWEST STYLUS PLUS SPM HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 792400
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 stylus plus handpiece overheated and burned a patient "slightly. " there was no intervention required.
 
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Brand NameMIDWEST STYLUS PLUS SPM
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, D-646 25
GM D-64625
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key6947966
MDR Text Key90204876
Report Number1419322-2017-00249
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 Number792400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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