MAUDE Adverse Event Report: MDT MICRO DIAMOND TECHNOLOGIES HENRY SCHEIN; DIAMOND SINGLE-USE FG 379-023C BUR

Catalog Number 104-6926

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2022

Event Type  Injury  

Event Description

The dentist was performing a filing procedure on a (b)(6) female patient when the diamond single-use bur came out of a 430sw handpiece and was swallowed by the patient.The patient was advised to go for a chest x-ray.

• Brand Name: HENRY SCHEIN
• Type of Device: DIAMOND SINGLE-USE FG 379-023C BUR
• Manufacturer (Section D): MDT MICRO DIAMOND TECHNOLOGIES; 2 hamal st.; afula, 18571 07; IS 1857107
• MDR Report Key: 14250793
• MDR Text Key: 290385606
• Report Number: 2411236-2022-00001
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022,04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 104-6926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2022
• Distributor Facility Aware Date: 04/15/2022
• Event Location: Other
• Date Report to Manufacturer: 04/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female