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 ZM2550 manufactured by Discus Dental, Llc.
[1363516]
The pt claims as a result of the procedure, that she experienced swelling of the upper and lower lip with a blister on the upper inside of the lip. The dentist ((b)(6)) prescribed peridex and warm salt water to use. The pt stated they went to the emergency room because, their lip was still swollen because (b)(6) "was no help. "
Patient Sequence No: 1, Text Type: D, B5
[8588720]
The discus technical specialist for zoom chairside whitening ((b)(4)) investigated the incident and evaluated the process/procedure(s) that (b)(6) office used in whitening the pt's teeth. It was strongly recommended that the dfu for the whitening procedure be followed; up to the including using all materials provided; most specifically the isolation retractors. The dfu provided with the kit was reviewed to make sure it contained best practice techniques to avoid uv exposure to lips and gums as well as initial and follow-up training.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2010-00002 |
| MDR Report Key | 1785048 |
| Report Source | 04,05 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-07-09 |
| Date of Event | 2010-06-08 |
| Date Facility Aware | 2010-06-09 |
| Report Date | 2010-07-09 |
| Date Reported to FDA | 2010-07-09 |
| Date Mfgr Received | 2010-06-09 |
| Device Manufacturer Date | 2007-01-18 |
| Date Added to Maude | 2012-03-14 |
| 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 | ZOOM WHITENING LAMP AND PROCEDURE KIT |
| Product Code | EEG |
| Date Received | 2010-07-15 |
| Model Number | ZM2550 |
| Catalog Number | ZM2550 |
| Lot Number | NA |
| ID Number | NA |
| 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 |