FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 18800826
·
Received February 28, 2024
Report
- Report Number
- 2411236-2024-00001
- Event Type
- Injury
- Date Received
- February 28, 2024
- Date of Event
- February 5, 2024
- Report Date
- February 28, 2024
- Manufacturer
- PRIMA DENTAL GROUP
- Product Code
- EJL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
WHILE A 52 YEAR OLD MALE PATIENT WAS HAVING A DENTAL SURGICAL PROCEDURE THE SURGICAL BUR DISLODGED FROM THE HANDPIECE. IT WAS SWALLOWED BY THE PATIENT. AS A RESULT THE PATIENT WAS ADMITTED TO THE HOSPITAL TO HAVE IT SURGICALLY REMOVED. THE BUR WAS SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 932098 | HENRY SCHEIN | SURGICAL BUR FG 171 | EJL | PRIMA DENTAL GROUP | 1514585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Hospitalization |