MAUDE Adverse Event Report: BRASSELER USA H031RS.31.010 1557 FG FISS 100P; CARBID BURS

Catalog Number 013745U5

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that several heads of 1557 fg fiss burs had broken off into the patients throat.The doctor reported that the bur heads were removed with suction and none have aspirated.

• Brand Name: H031RS.31.010 1557 FG FISS 100P
• Type of Device: CARBID BURS
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 11700329
• MDR Text Key: 257134693
• Report Number: 1032227-2021-00007
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): Y
• 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: 04/20/2021

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: No Information
• Device Catalogue Number: 013745U5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1