FDA Adverse Event
Injury
Summary report: N
W&H
MDR report key: 21861491
·
Received April 17, 2025
Report
- Report Number
- 3007007357-2025-00003
- Event Type
- Injury
- Date Received
- April 17, 2025
- Date of Event
- August 8, 2023
- Report Date
- April 17, 2025
- Manufacturer
- HANDPIECE HEADQUARTERS
- Product Code
- EFB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DENTAL BUR UTILIZED BECAME DETACHED FROM THE HANDPIECE, ENTERING PATIENT'S NOSE AND RESULTING TO BEING SWALLOWED BY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31981 | W&H | TURBINE | EFB | HANDPIECE HEADQUARTERS | W&H SYNEA TA-98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Other |