MAUDE Adverse Event Report: PALISADES DENTAL LLC IMPACT AIR 45; HANDPIECE, AIR POWERED DENTAL

Model Number IMPACT AIR 45

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/23/2018

Event Type  Injury  

Event Description

Burr came out during procedure.

• Brand Name: IMPACT AIR 45
• Type of Device: HANDPIECE, AIR POWERED DENTAL
• Manufacturer (Section D): PALISADES DENTAL LLC; englewood NJ 07631
• MDR Report Key: 7525546
• MDR Text Key: 108861327
• Report Number: MW5077317
• 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: 05/14/2018

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
• Device Operator: Health Professional
• Device Model Number: IMPACT AIR 45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2018
• 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: 41 YR