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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAR DENTAL STAR DENTAL/DENTALEZ GROUP HANDPIECE

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STAR DENTAL STAR DENTAL/DENTALEZ GROUP HANDPIECE Back to Search Results
Model Number 460 SW
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2017
Event Type  Injury  
Event Description
Dentist was treating patient when bur came out of the handpiece and might have been swallowed or aspirated.
 
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Brand NameSTAR DENTAL/DENTALEZ GROUP
Type of DeviceHANDPIECE
Manufacturer (Section D)
STAR DENTAL
lancaster PA 17601
MDR Report Key6493000
MDR Text Key72917340
Report NumberMW5069079
Device Sequence Number1
Product Code EFB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number460 SW
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/12/2017 Patient Sequence Number: 1
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