MAUDE Adverse Event Report: PALISADES DENTAL LLC PALISADES DENTAL; HAND PIECE

Model Number IMPACT AIR 45

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Patient was having a dental procedure completed when the bur came out of the handpiece and was swallowed.

• Brand Name: PALISADES DENTAL
• Type of Device: HAND PIECE
• Manufacturer (Section D): PALISADES DENTAL LLC; englewood NJ 07631
• MDR Report Key: 6950950
• MDR Text Key: 89510078
• Report Number: MW5072757
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPACT AIR 45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• 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: 65 YR