MAUDE Adverse Event Report: UNK ML MAXIMA-N; BUR, DENTAL

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/07/2016

Event Type  malfunction  

Event Description

Patient was having a tooth drilled when the bur came out of the hand piece and was swallowed.Patient was sent for a chest x-ray to verify the item was not aspirated.(b)(6).

• Brand Name: MAXIMA-N
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): UNK ML
• MDR Report Key: 6099256
• MDR Text Key: 59901130
• Report Number: MW5065988
• Device Sequence Number: 1
• Product Code: EJL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR