MAUDE Adverse Event Report: BRASSELER U.S.A. DENTAL, LLC BRIO440 HIGHSPEED; DENTAL HANDPIECE ATTACHMENT

Catalog Number 5026059U0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Abrasion (1689)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

A repair call was requested for the unit.When the unit was received, a note was inside the package, indicating tissue below patient's tongue was cut.Follow up with the office noted that the back cap 'shot off' of the attachment and hit the patient's #8 tooth.No immediate damage to that tooth was noted at the time.The patient received a slight abrasion from the bur cutting underneath the tongue.No medical intervention.

• Brand Name: BRIO440 HIGHSPEED
• Type of Device: DENTAL HANDPIECE ATTACHMENT
• 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 ; 1 brasseler blvd; savannah, GA 31419 ; 9129205535
• MDR Report Key: 8597370
• MDR Text Key: 145669895
• Report Number: 1032227-2019-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5026059U0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 42 YR