MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN INC.; CARBIDE BUR

Catalog Number 900-4368

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2019

Event Type  Injury  

Event Description

While delivering a crown on a (b)(6) male patient, the entire bur fell out of the handpiece into the patient's mouth.The patient swallowed the bur and was sent for an x-ray.The dr.Confirmed the patient was fine and no additional medical attention was required.The dr.Stated there were no changes in the patient's condition reported.

• Brand Name: HENRY SCHEIN INC.
• Type of Device: CARBIDE BUR
• Manufacturer (Section D): PRIMA DENTAL GROUP; stephenson drive waterwells; business park; gloucester, GL2 2 AG; UK GL2 2AG
• MDR Report Key: 8304911
• MDR Text Key: 135003460
• Report Number: 2411236-2019-00001
• 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: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900-4368
• Device Lot Number: 1165450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/22/2019
• Event Location: Other
• Date Report to Manufacturer: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR