FDA Adverse Event
Malfunction
Summary report: N
ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT
MDR report key: 3823052
·
Received January 17, 2014
Report
- Report Number
- 1419322-2014-00001
- Event Type
- Malfunction
- Date Received
- January 17, 2014
- Report Date
- December 30, 2013
- Manufacturer
- DENTSPLY PROFESSIONAL
- Product Code
- EKX
- PMA / PMN Number
- K031145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING THIS DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem · 1
IN THIS EVENT A DOCTOR REPORTED THAT AN ESTYLUS 1:5 HANDPIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46097 | ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT | EKX | DENTSPLY PROFESSIONAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |