FDA Adverse Event
Injury
Summary report: N
DIAMOND BUR
MDR report key: 8474017
·
Received April 1, 2019
Report
- Report Number
- MW5085511
- Event Type
- Injury
- Date Received
- April 1, 2019
- Date of Event
- March 7, 2019
- Report Date
- March 28, 2019
- Manufacturer
- UNK
- Product Code
- DZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WAS HAVING DENTAL PROCEDURE WHEN DIAMOND BUR LEAD CAME OFF AND REQUIRED INTERVENTION BY STAFF TO AVOID SWALLOWING OF BUR. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262322 | DIAMOND BUR | DENTAL INSTRUMENT, DIAMOND | DZP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |