FDA Adverse Event
Malfunction
Summary report: N
PROPHY ANGLE SCREW TYPE
MDR report key: 807189
·
Received January 2, 2007
Report
- Report Number
- 2411236-2006-19268
- Event Type
- Malfunction
- Date Received
- January 2, 2007
- Date of Event
- December 5, 2006
- Report Date
- December 6, 2006
- Manufacturer
- NAKANISHI INC.
- Product Code
- KBW
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WHILE POLISHING THE PT'S TEETH, THE PROPHY ANGLE BURNED THE INSIDE OF THE PT'S MOUTH AND LEFT AN ULCER. NO IMMEDIATE MEDICAL ATTENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROPHY ANGLE SCREW TYPE | DENTAL | KBW | NAKANISHI INC. | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |