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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN EAGLE INSTRUMENTS AMERICAN EAGLE INSTRUMENTS; PERIODONTAL SCALER
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AMERICAN EAGLE INSTRUMENTS AMERICAN EAGLE INSTRUMENTS; PERIODONTAL SCALER Back to Search Results
Model Number AESETXPX
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2017
Event Type  malfunction  
Event Description
"the hygienist was using the instrument on a patient to perform scaling when the tip snapped off in the patients mouth.The tip went up the suction and the patient was not hurt at all.".
 
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Brand Name
AMERICAN EAGLE INSTRUMENTS
Type of Device
PERIODONTAL SCALER
Manufacturer (Section D)
AMERICAN EAGLE INSTRUMENTS
6575 butler creek road
missoula MT 59808
Manufacturer (Section G)
AMERICAN EAGLE INSTRUMENTS
6575 butler creek road
missoula MT 59808
Manufacturer Contact
ben palmer
6575 butler creek road
missoula, MT 59808
4065327316
MDR Report Key7303320
MDR Text Key101476477
Report Number3027615-2017-00002
Device Sequence Number1
Product Code EMN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Dental Hygienist
Remedial Action Inspection
Type of Report Initial
Report Date 02/28/2018
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 Dental Hygienist
Device Model NumberAESETXPX
Device Catalogue NumberAESETXPX
Device Lot Number7GS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/22/2017
Initial Date Manufacturer Received 01/20/2018
Initial Date FDA Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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