FDA Adverse Event
Malfunction
Summary report: N
LASERWHITE 20 WHITENING GEL
MDR report key: 2380630
·
Received October 19, 2011
Report
- Report Number
- 2027755-2011-00002
- Event Type
- Malfunction
- Date Received
- October 19, 2011
- Date of Event
- July 29, 2011
- Report Date
- September 8, 2011
- Manufacturer
- BIOLASE TECHNOLOGY, INC.
- Product Code
- GEX
- PMA / PMN Number
- K083595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTAL HYGIENIST
Narratives
Additional Manufacturer Narrative · 1
THE TIP OF SYRINGE, INCLUDING WHITENING GEL, WAS OCCLUDED AND ONCE THE USER TRIED TO FORCE THE SYRINGE, THE TIP POPPED OFF AND THE GEL EXITED THE SYRINGE QUICKLY, HENCE SPILLING BEYOND THE TEETH. THE PT EXPERIENCED BURNING SENSATION, BUT NO REMEDIAL ACTION WAS REQUIRED AND THE PT DID NOT EXPERIENCE ANY SERIOUS INJURIES.
Description of Event or Problem · 1
LASER WHITENING GEL SPILLED OVER FROM THE SYRINGE AND GOT INTO PT'S ORAL TISSUES INCLUDING PT'S LIPS. THE WHITENING GEL IS USED WITH EZLASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASERWHITE 20 WHITENING GEL | SURGICAL DIODE LASER | GEX | BIOLASE TECHNOLOGY, INC. | 7400030 | B6534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |