MAUDE Adverse Event Report: HENRY SCHEIN HANDPIECE ; BUR, DENTAL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Dr was suing dental hand piece when the bur came out of the hand piece and pt swallowed it.Fda safety report id# (b)(4).

• Brand Name: HANDPIECE
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): HENRY SCHEIN ; melville NY 11747
• MDR Report Key: 8541122
• MDR Text Key: 142924336
• Report Number: MW5086065
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other