FDA Adverse Event
Injury
Summary report: N
DIATECH DIAMOND INSTRUMENTS
MDR report key: 15184319
·
Received August 8, 2022
Report
- Report Number
- 9613375-2022-00001
- Event Type
- Injury
- Date Received
- August 8, 2022
- Date of Event
- June 14, 2022
- Report Date
- June 16, 2022
- Manufacturer
- COLTENE/WHALEDENT AG
- Product Code
- DZP
- UDI-DI
- J006210857DD0
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SEE ATTACHMENT.
Description of Event or Problem · 0
AN ISSUE WITH A DENTAL BURR THAT OCCURRED IN THE DENTAL CLINIC AT (B)(6) HOSPITAL. A FLAME-D862-012-8.0/ML WAS USED IN A PROCEDURE, AND A TIP BROKE OFF AND WAS SWALLOWED. NO REPORTED INJURY BUT THE PATIENT WAS HOSPITALIZED. PATIENT WAS SUBSEQUENTLY DISCHARGED WITH NO OTHER KNOWN NEGATIVE IMPACT AT THIS TIME. HOSPITAL WROTE AT (B)(6) 2022: "UNFORTUNATELY, WE ARE UNABLE TO PROVIDE ADDITIONAL INFORMATION AT THIS TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2371189 | DIATECH DIAMOND INSTRUMENTS | DIAMOND DENTAL BUR | DZP | COLTENE/WHALEDENT AG | 210857DD | L15788 | J006210857DD0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |