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

Model Number SURGIPRO45

Device Problems Vibration (1674); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2022

Event Type  Injury  

Event Description

Vibration dislodged surgical bur and pt swallowed it.

• Brand Name: HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): HENRY SCHEIN, INC.; 41 weaver rd.; denver PA 17517
• MDR Report Key: 14162204
• MDR Text Key: 289771785
• Report Number: MW5109193
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SURGIPRO45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 64 YR