FDA Adverse Event
Injury
Summary report: N
SS WHITE DENTAL BUR
MDR report key: 21691270
·
Received March 25, 2025
Report
- Report Number
- MW5168192
- Event Type
- Injury
- Date Received
- March 25, 2025
- Date of Event
- March 11, 2025
- Report Date
- March 19, 2025
- Manufacturer
- SS WHITE BURS LLC.
- Product Code
- EJL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DENTAL BUR SLOWLY SLIPPED OUT FROM HANDPIECE WHEN OPERATING IN PATIENT'S MOUTH. DID NOT COMPLETELY DISLODGE FROM HANDPIECE. NO INTRAORAL INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415906 | SS WHITE DENTAL BUR | BUR, DENTAL | EJL | SS WHITE BURS LLC. | L04L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Female | Required Intervention |