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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN; CARBIDE SURGICAL BUR FG 557
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PRIMA DENTAL GROUP HENRY SCHEIN; CARBIDE SURGICAL BUR FG 557 Back to Search Results
Catalog Number 100-8502
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2017
Event Type  Injury  
Event Description
Reference report number mw5068737.The dentist was sectioning a tooth of a patient when the bur broke in half.The dentist took a panoramic xray of the patient's mouth at the office and saw that a piece of the bur that broke was still in an area of the patient's cheek.The patient was then asked to rinse their mouth out.After the patient rinsed their mouth the office took a second panoramic xray at the office and did not see anything.As a precautionary measure the office decided to send the patient to an offsite facility for a chest xray.
 
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Brand Name
HENRY SCHEIN
Type of Device
CARBIDE SURGICAL BUR FG 557
Manufacturer (Section D)
PRIMA DENTAL GROUP
stephenson drive
business park
gloucester, GL2 2 AG
UK  GL2 2AG
MDR Report Key6515728
MDR Text Key73491908
Report Number2411236-2017-00001
Device Sequence Number1
Product Code EJL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/24/2017,04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Catalogue Number100-8502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2017
Distributor Facility Aware Date04/14/2017
Event Location Other
Date Report to Manufacturer04/24/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age39 YR
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