MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2012-05-10 for BRITESMILE LAMP & WHITENING GEL 25% BS4000 manufactured by Discus Dental, Llc.
[2872391]
The pt had the whitening procedure performed on or before (b)(6) 2012, at (b)(6) office. Right after the procedure her upper lips were swollen with slight white spots on the inner lip. Had no sensitivity.
Patient Sequence No: 1, Text Type: D, B5
[10022056]
During the investigative interview with the dentist's office follow up training over the phone was conducted and documented in the complaint file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2012-00001 |
| MDR Report Key | 2650140 |
| Report Source | 04,05 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-09 |
| Date of Event | 2012-03-22 |
| Date Facility Aware | 2012-03-22 |
| Report Date | 2012-05-10 |
| Date Reported to FDA | 2012-05-10 |
| Date Mfgr Received | 2012-08-22 |
| Device Manufacturer Date | 2012-01-03 |
| Date Added to Maude | 2012-08-03 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 8550 HIGUERA ST. |
| Manufacturer City | CULVER CITY CA 90232 |
| Manufacturer Country | US |
| Manufacturer Postal | 90232 |
| Manufacturer Phone | 3108458336 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRITESMILE LAMP & WHITENING GEL 25% |
| Product Code | EEG |
| Date Received | 2012-05-10 |
| Model Number | BS4000 |
| Catalog Number | BS4000 |
| Lot Number | BS4000BS401665 |
| ID Number | NA |
| Device Expiration Date | 2013-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | CULVER CITY CA 90232 US 90232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-10 |