FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 14250793
·
Received April 29, 2022
Report
- Report Number
- 2411236-2022-00001
- Event Type
- Injury
- Date Received
- April 29, 2022
- Date of Event
- April 8, 2022
- Report Date
- April 15, 2022
- Manufacturer
- MDT MICRO DIAMOND TECHNOLOGIES
- Product Code
- DZP
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE DENTIST WAS PERFORMING A FILING PROCEDURE ON A (B)(6) FEMALE PATIENT WHEN THE DIAMOND SINGLE-USE BUR CAME OUT OF A 430SW HANDPIECE AND WAS SWALLOWED BY THE PATIENT. THE PATIENT WAS ADVISED TO GO FOR A CHEST X-RAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204454 | HENRY SCHEIN | DIAMOND SINGLE-USE FG 379-023C BUR | DZP | MDT MICRO DIAMOND TECHNOLOGIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Other |