FDA Adverse Event
Injury
Summary report: N
WS-75 CONTRA ANGLE 20:1
MDR report key: 8203359
·
Received December 28, 2018
Report
- Report Number
- 0001038806-2018-01058
- Event Type
- Injury
- Date Received
- December 28, 2018
- Report Date
- December 28, 2018
- Manufacturer
- W&H IMPEX INC
- Product Code
- HTW
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THAT WHEN THEY PRESSED DOWN ON THE FOOT PEDAL OF THE DRILL UNIT, THEY RECEIVED A (THERMOMETER) TEMPERATURE GAUGE THAT THE UNIT IS OVERHEATING. THE HAND PIECE IS ALSO GETTING HOT AND WOULD STOP SPINNING. THE ERROR OCCURRED DURING A PROCEDURE AND THEY WERE UNABLE TO COMPLETE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1043978 | WS-75 CONTRA ANGLE 20:1 | DRILLING UNIT ACCESSORIES | HTW | W&H IMPEX INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |