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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIAMOND BUR ; DENTAL INSTRUMENT, DIAMOND
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DIAMOND BUR ; DENTAL INSTRUMENT, DIAMOND Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/07/2019
Event Type  Injury  
Event Description
Pt was having dental procedure when diamond bur lead came off and required intervention by staff to avoid swallowing of bur.(b)(6).
 
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Brand Name
DIAMOND BUR
Type of Device
DENTAL INSTRUMENT, DIAMOND
MDR Report Key8474017
MDR Text Key140800526
Report NumberMW5085511
Device Sequence Number1
Product Code DZP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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