MAUDE Adverse Event Report: BRASSELER U.S.A. DENTAL, LLC BRASSELER USA CARBIDE BUR; DENTAL CARBIDE BUR

Model Number H7.33.008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

No product was returned.Burs from inventory were checked.All burs checked were found to meet specifications.Unable to determine cause of bur walk out, but may be due to a worn handpiece collet.This is an isolated occurrence.

Event Description

Doctor noted bur would not stay in handpiece and a patient had one go down their throat.Patient was not sent for x-rays initially because was breathing fine and no issues after incident.Bur was found in stool later the next day.Follow up visit to dental office on (b)(6) 2017 noted patient was doing fine.

• Brand Name: BRASSELER USA CARBIDE BUR
• Type of Device: DENTAL CARBIDE BUR
• Manufacturer (Section D): BRASSELER U.S.A. DENTAL, LLC; one brasseler blvd; savannah GA 31419
• Manufacturer (Section G): BRASSELER U.S.A. DENTAL, LLC; one brasseler blvd; savannah GA 31419
• Manufacturer Contact: giovanny espinosa ; one brasseler blvd; savannah, GA 31419
• MDR Report Key: 7071875
• MDR Text Key: 94318030
• Report Number: 1032227-2017-00006
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: H7.33.008
• Device Catalogue Number: 000193U7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 78 YR