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U.S. Department of Health and Human Services

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

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DENTSPLY PROFESSIONAL MIDWEST STYLUS ATC HANDPIECE HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 882300
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 atc mini handpiece overheated and burned a patient's cheek. There was no intervention required.
 
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Brand NameMIDWEST STYLUS ATC HANDPIECE
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer (Section G)
DENTSPLY PROFESSIONAL
901 west oakton st.
des plaines IL 60018
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key6919589
MDR Text Key89495654
Report Number1419322-2017-00243
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003518
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 10/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number882300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/05/2017
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

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