MAUDE Adverse Event Report: AZDENT WHITE STONES; POINT, ABRASIVE

Model Number WHITE STONES (PRF2-54)

Device Problem Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

White stone bur exploded in patient's mouth upon normal use.Consistent with multiple burs in package.

• Brand Name: AZDENT WHITE STONES
• Type of Device: POINT, ABRASIVE
• MDR Report Key: 16357488
• MDR Text Key: 309366248
• Report Number: MW5114864
• Device Sequence Number: 1
• Product Code: EHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WHITE STONES (PRF2-54)
• Device Catalogue Number: 1470500112
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic