FDA Adverse Event
Other
Summary report: N
430 SWL DENTAL HANDPIECE (LESS SWIVEL)
MDR report key: 47594
·
Received November 8, 1996
Report
- Report Number
- 2520265-1996-00014
- Event Type
- Other
- Date Received
- November 8, 1996
- Date of Event
- September 3, 1996
- Report Date
- November 8, 1996
- Manufacturer
- DEN-TAL-EZ, INC
- Product Code
- EFB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE DENTIST BURNED THE INSIDE OF A PT'S CHEEK WHILE DOING A ROUTINE CROWN. NO MEDICAL TREATMENT REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 430 SWL DENTAL HANDPIECE (LESS SWIVEL) | AIR-POWERED DENTAL HANDPIECE | EFB | DEN-TAL-EZ, INC | 261307 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |