MAUDE Adverse Event Report: MAXIMA PRO 45 HAND PIECE; HANDPIECE, AIR-POWERED, DENTAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2022

Event Type  Injury  

Event Description

During extraction, pt swallowed burr.Henry schein.

• Brand Name: MAXIMA PRO 45 HAND PIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• MDR Report Key: 15250579
• MDR Text Key: 298343151
• Report Number: MW5111574
• 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: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male