FDA Adverse Event
Other
Summary report: N
SL3 LASER
MDR report key: 2216405
·
Received July 11, 2011
Report
- Report Number
- 2032714-2011-00004
- Event Type
- Other
- Date Received
- July 11, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 8, 2011
- Manufacturer
- DISCUS DENTAL, LLC
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
REVIEWED THE DHR FOR THIS DEVICE AND FOUND NO OUT OF SPECIFICATIONS CONDITION. HAVE CONTACTED THE CUSTOMER IN AN EFFORT TO HAVE THE DEVICE RETURNED FOR A FULL EVAL.
Description of Event or Problem · 1
THE SL3 BURNED AND SHOCKED THE DOCTOR WHILE DOING A PROCEDURE. THE UNI-FIBER CORD APPEARED TO BE DAMAGED ON THE FIBER OPTIC AT THE END OF THE HAND PIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SL3 LASER | GEX | DISCUS DENTAL, LLC | LR2002 | LR2002000246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PERFORMING A PROCEDURE.| NOT APPLICABLE, THE DOCTOR WAS INJURED WHILE |