FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 15729416
·
Received November 4, 2022
Report
- Report Number
- 2411236-2022-00005
- Event Type
- Injury
- Date Received
- November 4, 2022
- Date of Event
- June 28, 2022
- Report Date
- October 13, 2022
- Manufacturer
- PRIMA DENTAL GROUP
- Product Code
- EJL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A 62 YEAR OLD MALE PATIENT WAS HAVING A FULL MOUTH EXTRACTION SURGERY PROCEDURE BEING PERFORMED WHEN THEY SWALLOWED A BUR. THE PATIENT HAD WENT FOR MEDICAL TREATMENT WHERE AN X-RAY WAS TAKEN AT EMERGENCY CENTER. THERE WERE NO FINDINGS AND HAVE SINCE RETURNED TO THE DENTAL OFFICE WITH NO COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2783379 | HENRY SCHEIN | CARBIDE BUR SURGICAL BONE FG 541 | EJL | PRIMA DENTAL GROUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Other |