MAUDE Adverse Event Report: PRIMA DENTAL HENRY SCHEIN; CARBIDE BUR T&F 12 BLADE

Catalog Number 900-4357

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2017

Event Type  Injury  

Event Description

During a filling procedure a dental hygienist reported that the bur came out of a handpiece and was swallowed by the patient.As a precautionary measure the patient went for an x-ray that revealed the bur was in her small intestine.Please note the user facility filed a report for this incident against the handpiece that this bur was used with on (b)(6) 2017.

• Brand Name: HENRY SCHEIN
• Type of Device: CARBIDE BUR T&F 12 BLADE
• Manufacturer (Section D): PRIMA DENTAL; stephenson drive; business park; gloucester, GL2 2 AG; UK GL2 2AG
• MDR Report Key: 7161958
• MDR Text Key: 96335757
• Report Number: 2411236-2017-00005
• 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: Dental Hygienist
• Type of Report: Initial
• Report Date: 01/03/2018,12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Catalogue Number: 900-4357
• 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: 01/03/2018
• Distributor Facility Aware Date: 12/07/2017
• Event Location: Other
• Date Report to Manufacturer: 01/03/2018
• 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: 70 YR