MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-07 for LASERWHITE 20 WHITENING GEL 7400030 manufactured by Biolase Technology.
[2551887]
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.
Patient Sequence No: 1, Text Type: D, B5
[9754535]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027755-2012-00001 |
| MDR Report Key | 2489362 |
| Report Source | 06 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-02-07 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JACKSON SOWIN |
| Manufacturer Street | 4 CROMWELL |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LASERWHITE 20 WHITENING GEL |
| Generic Name | LASERWHITE 20 |
| Product Code | ILY |
| Date Received | 2012-03-07 |
| Returned To Mfg | 2012-02-08 |
| Model Number | 7400030 |
| Catalog Number | 7400030 |
| Lot Number | B5WG3 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOLASE TECHNOLOGY |
| Manufacturer Address | 4 CROMWELL IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-07 |