LASERWHITE 20 WHITENING GEL
Received Mar 7, 2012 · Event occurred Feb 7, 2012
Report 2027755-2012-00001 · MDR key 2489362
Device
Generic name
Laserwhite 20
Manufacturer
Biolase TechnologyModel number
7400030Catalog number
7400030
Lot number
B5WG3
Product problems
- Gel Leak
Patient
Not reported
- Burning Sensation
- Discomfort
Narrative
Description of Event or Problem
LASER WHITENING GEL SPILLED OVER FROM THE SYRINGE AND GOT ON PT'S ORAL TISSUES INCLUDING MOUTH AND LIP. IT ALSO GOT ON HYGIENISTS HAND. PT COMPLAINED OF HEAT AND DISCOMFORT WHEN GEL WAS APPLIED TO TEETH. THE WHITENING GEL WAS USED WITH THE EZLASE LASER SYSTEM.
Additional Manufacturer Narrative
PRESSURE BUILD-UP CAUSED TIP TO DETACH FROM SYRINGE AND GEL GOT ON PT'S MOUTH AND LIP AND HYGIENIST'S HAND. GEL WAS REMOVED FROM ALL TISSUE BY RINSING WITH COLD WATER. THE PT AND HYGIENIST WERE NOT SERIOUSLY INJURED. ALSO, THE PT COMPLAINED OF HEAT AND DISCOMFORT WHEN THE GEL WAS APPLIED TO HER TEETH. (B)(4).