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U.S. Department of Health and Human Services

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

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PALISADES DENTAL LLC PALISADES DENTAL HAND PIECE Back to Search Results
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.
 
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Brand NamePALISADES DENTAL
Type of DeviceHAND PIECE
Manufacturer (Section D)
PALISADES DENTAL LLC
englewood NJ 07631
MDR Report Key6950950
MDR Text Key89510078
Report NumberMW5072757
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 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIMPACT AIR 45
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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