FDA Adverse Event
Injury
Summary report: N
SOLO DIAMOND
MDR report key: 18544785
·
Received January 19, 2024
Report
- Report Number
- 2511556-2023-00008
- Event Type
- Injury
- Date Received
- January 19, 2024
- Date of Event
- November 16, 2023
- Report Date
- January 17, 2024
- Manufacturer
- PREMIER DENTAL PRODUCTS COMPANY
- Product Code
- DZP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE DIAMOND BUR EJECTED IN THE PATIENTS MOUTH AND WAS SWALLOWED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1141261 | SOLO DIAMOND | DIAMOND, DENTAL BURR | DZP | PREMIER DENTAL PRODUCTS COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |