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U.S. Department of Health and Human Services

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

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PALISADES DENTAL LLC IMPACT AIR 45; HANDPIECE, AIR POWERED DENTAL Back to Search Results
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.
 
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Brand Name
IMPACT AIR 45
Type of Device
HANDPIECE, AIR POWERED DENTAL
Manufacturer (Section D)
PALISADES DENTAL LLC
englewood NJ 07631
MDR Report Key7525546
MDR Text Key108861327
Report NumberMW5077317
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberIMPACT AIR 45
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/17/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
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