FDA Adverse Event
Other
Summary report: N
SL3 LASER
MDR report key: 2216406
·
Received July 11, 2011
Report
- Report Number
- 2032714-2011-00003
- Event Type
- Other
- Date Received
- July 11, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 8, 2011
- Manufacturer
- DISCUS DENTAL, LLC
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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
THIS INCIDENT DID NOT INVOLVE THE PT OR A PROCEDURE WITH A PT. THE DENTAL HYGIENIST EXPLAINED THAT THE INCIDENT OCCURRED THE FIRST TIME SHE USED THE LASER. SHE DID NOT SEE THE AIMING BEAM SO SHE CHECKED EVERYTHING; WHEN SHE TOUCHED THE PART WHERE THE HAND PIECE AND THE UNIFIBER CONNECT, SHE FELT A BURNING SENSATION. THE BURN IS NOW A BLISTER BETWEEN THE INDEX FINGER AND THE THUMB. SHE ADVISED THAT SHE IS OK NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SL3 LASER | GEX | DISCUS DENTAL, LLC | LR2002 | LR2002000200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | NOT APPLICABLE, A PROCEDURE WAS NEVER STARTED. |