MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for AMERICAN EAGLE INSTRUMENTS AESETXPX manufactured by American Eagle Instruments.
[101476477]
"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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3027615-2017-00002 |
| MDR Report Key | 7303320 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date of Event | 2017-11-22 |
| Date Facility Aware | 2017-11-22 |
| Date Mfgr Received | 2018-01-20 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BEN PALMER |
| Manufacturer Street | 6575 BUTLER CREEK ROAD |
| Manufacturer City | MISSOULA MT 59808 |
| Manufacturer Country | US |
| Manufacturer Postal | 59808 |
| Manufacturer Phone | 4065327316 |
| Manufacturer G1 | AMERICAN EAGLE INSTRUMENTS |
| Manufacturer Street | 6575 BUTLER CREEK ROAD |
| Manufacturer City | MISSOULA MT 59808 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59808 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMERICAN EAGLE INSTRUMENTS |
| Generic Name | PERIODONTAL SCALER |
| Product Code | EMN |
| Date Received | 2018-02-28 |
| Returned To Mfg | 2018-01-20 |
| Model Number | AESETXPX |
| Catalog Number | AESETXPX |
| Lot Number | 7GS |
| Operator | DENTAL HYGIENIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN EAGLE INSTRUMENTS |
| Manufacturer Address | 6575 BUTLER CREEK ROAD MISSOULA MT 59808 US 59808 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |