FDA Adverse Event
Other
Summary report: N
SL3 LASER
MDR report key: 2216404
·
Received July 11, 2011
Report
- Report Number
- 2032714-2011-00005
- Event Type
- Other
- Date Received
- July 11, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 8, 2011
- Manufacturer
- DISCUS DENTAL, LLC
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
THERE WAS A CRACK IN THE UNI-FIBER AND THE DOCTOR BURNED HIMSELF ON THE PALM OF HIS HAND. IT DID HEAL AND NO PERMANENT MARK LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SL3 LASER | GEX | DISCUS DENTAL, LLC | LR2002 | LR2002000297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PROCEDURE OR NOT.| NOT APPLICABLE, IT IS NOT KNOWN AT THIS TIME IF| THE DOCTOR WAS INJURED WHILE PERFORMING A |