MAUDE Adverse Event Report: DENTALEZ, INC., STARDENTAL DIVISION BUR; INSTRUMENT, DIAMOND, DENTAL

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2021

Event Type  Injury  

Event Description

Bur disengaged from hand piece and pt swallowed it.

• Brand Name: BUR
• Type of Device: INSTRUMENT, DIAMOND, DENTAL
• Manufacturer (Section D): DENTALEZ, INC., STARDENTAL DIVISION
• MDR Report Key: 14111298
• MDR Text Key: 289328679
• Report Number: MW5108968
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male