MAUDE Adverse Event Report: HENRY SCHEIN, INC. HAND PIECE; HANDPIECE, AIR-POWERED, DENTAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Restorations with flame "multifluted" carbide bur, the bur came out of the high speed handpiece and pt swallowed it.

• Brand Name: HAND PIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): HENRY SCHEIN, INC.; 135 duryea road, e-355; melville NY 11747
• MDR Report Key: 14111329
• MDR Text Key: 289348816
• Report Number: MW5108970
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male