FDA Adverse Event
Injury
Summary report: N
STAR DENTAL HANDPIECE
MDR report key: 6541143
·
Received May 1, 2017
Report
- Report Number
- MW5069530
- Event Type
- Injury
- Date Received
- May 1, 2017
- Date of Event
- April 19, 2017
- Report Date
- May 1, 2017
- Manufacturer
- STAR DENTAL
- Product Code
- EJH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DENTIST WAS USING HANDPIECE WHEN SHE NOTICED THAT BURR WAS WOBBLING AND ULTIMATELY CAME OUT OF THE HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315475 | STAR DENTAL HANDPIECE | ALLOY, METAL, BASE | EJH | STAR DENTAL | 430 SW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |