MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2011-03-15 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2550 manufactured by Discus Dental, Llc.
[1955069]
The patient had the procedure performed on or before (b)(6) 2011 at (b)(6) office. She called in to complain to (b)(6) office on (b)(6) 2011 claiming she had swollen lips with slight blistering and that she had gone to the emergency room because of it.
Patient Sequence No: 1, Text Type: D, B5
[9088979]
The discus technical specialist for zoom chairside whitening ((b)(4)) investigated the incident and evaluated the process/procedure(s) that dr (b)(6) staff used in whitening the patient's teeth. It was determined during the interview process that the retractor provided with the kit was not used. This particular retractor has been (was) designed to wrap around the lips and protect them from uv light emissions from the chairside lamp. Using any "off label" retractors not provided with the kit can increase the risk for tissue exposure to uv rays. The kit does contain a warning card to the end user to use all items in the kit, in the order required with no substitutions. It was strongly recommended that the dfu for the whitening procedure be followed. The dfu, most specifically isolation requirements and techniques were reviewed with the person who originally performed the procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2011-00001 |
| MDR Report Key | 2026830 |
| Report Source | 04,05 |
| Date Received | 2011-03-15 |
| Date of Report | 2011-02-25 |
| Date of Event | 2011-01-27 |
| Date Facility Aware | 2011-01-27 |
| Report Date | 2011-02-25 |
| Date Reported to FDA | 2011-02-25 |
| Date Mfgr Received | 2011-01-27 |
| Device Manufacturer Date | 2006-07-22 |
| Date Added to Maude | 2012-08-24 |
| 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 |
| 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 | 2011-03-15 |
| Model Number | ZM2550 |
| Catalog Number | ZM2550 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| 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. Hospitalization | 2011-03-15 |