MAUDE Adverse Event Report: BEAVERS DENTAL , DIV. SYBRON CANADA, LTD. BLUWHITE TAPERED FISSURE OPERATIVE CARBIDE; BUR, DENTAL

Catalog Number FG169L

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

A doctor's office alleged patient had swallowed a bur and had gone to the hospital to have it surgically removed.No further information has been provided at this time.Further information has been requested regarding the patient's health status and will be provided in a follow up report if becomes available.A visual evaluation was performed on the unused returned product, yielding results within specifications.A review of the device history record was not conducted as specific lot number information was not provided.Patient's age was not provided.

Event Description

A doctor's office alleged a patient had swallowed a bluwhite tapered fissure operative carbide bur type - fg 169l that had separated from the handpiece during a procedure.

Manufacturer Narrative

This follow up is an update in regards to the estimated date of event provided by the doctor.The doctor only provided the month, so the date was entered as (b)(6) 2016.

• Brand Name: BLUWHITE TAPERED FISSURE OPERATIVE CARBIDE
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): BEAVERS DENTAL , DIV. SYBRON CANADA, LTD.; 55 laurier drive; morrisburg, ontario K0C 1 X0; CA K0C 1X0
• Manufacturer Contact: mark dzendzel ; 1717 w collins ave; orange 92867 ; 7145167634
• MDR Report Key: 6052461
• MDR Text Key: 58245621
• Report Number: 9610862-2016-00001
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FG169L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DENTAL BUR HANDPIECE
• Patient Outcome(s): Hospitalization; Required Intervention