MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2010-07-15 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2604P manufactured by Discus Dental, Llc.
[1575819]
The pt had the procedure on (b)(6) 2010 and came back to dr. (b)(6)'s office on (b)(6) 2010 complaining of a burning sensation in the upper and lower lips and a burning sensation/pain in right buccal and lingual (gums). Dr lyew prescribed 400 mg iodine. Later that evening, the pt went to the emergency room claiming she could not breathe due to swelling of her lips. The emergency room personnel (dr. ) prescribed pregnazone, vicodin and clendamidacine. Dr. (b)(6) did not report this incident to discus dental until (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[8725234]
The discus technical specialist for zoom chairside whitening (trevor rucker) investigated the incident and evaluated the process/procedure(s) that dr. (b)(6)'s office used in whitening the pt's teeth. It was strongly recommended that the dfu for the whitening procedure be followed. It could not be determined by interview as to why the lips were swollen with blisters, since proper procedure and materials were used as directed; however, the gum irritation and sensitivity may have occurred because the barrier material was applied too thick, possibly resulting in some high heat to the gums when the uv light was activated. The dfu was reviewed to make sure it contained best practice techniques to avoid uv exposure to the gums as well as initial training and follow-up training recommendations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2010-00003 |
| MDR Report Key | 1785066 |
| Report Source | 04,05 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-05-31 |
| Date Facility Aware | 2010-05-31 |
| Report Date | 2010-07-09 |
| Date Reported to FDA | 2010-07-09 |
| Date Mfgr Received | 2010-06-09 |
| Device Manufacturer Date | 2010-02-22 |
| Date Added to Maude | 2011-08-26 |
| 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 | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM WHITENING LAMP AND PROCEDURE KIT |
| Product Code | EEG |
| Date Received | 2010-07-15 |
| Model Number | ZM2604P |
| Catalog Number | ZM2604P |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | CULVER CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-07-15 |