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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDPIECE; HIGH SPEED HANDPIECE
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HANDPIECE; HIGH SPEED HANDPIECE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Airway Obstruction (1699)
Event Date 03/13/2017
Event Type  Injury  
Event Description
Burr came out of high speed handpiece and patient swallowed the burr.
 
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Brand Name
HANDPIECE
Type of Device
HIGH SPEED HANDPIECE
MDR Report Key6440510
MDR Text Key71164384
Report Number6440510
Device Sequence Number1
Product Code EFB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2017
Distributor Facility Aware Date03/13/2017
Event Location Other
Date Report to Manufacturer03/20/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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