MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-10 for ZOOM CHAIRSIDE WHITENING manufactured by Discus Dental, Llc.
[4458047]
On (b)(6) 2014, the office reported that a patient's front tooth is translucent after zoom treatment.
Patient Sequence No: 1, Text Type: D, B5
[12162346]
Expiration date: 01/01/2015. 07/01/2013. An extensive investigation was conducted for complaint #(b)(4). On (b)(6) 2014, the office reported that a patient's front tooth is translucent after zoom treatment. The dental office disposed the zoom whitening chairside lot information. In order to initiate testing of the retains, the sales history for the dental office in the last 12 months was reviewed. It was decided to test all three lots that were shipped to the dental office in the last 12 months. The investigation included review of batch history record for chairside gel 22-3764 lot #s 14069020, 13203060 and 13129001. In addition, the retain sample for sku #22-3764 lot #s 14069020, 13203060 and 13129001 were tested and they were found to be within specifications. No other quality issue was revealed during the review of said records. The complaint record states that the patient's teeth were white before the whitening procedure so there was no need to take before photos. Based on the investigation, it appears ths is an isolated incident. Discus dental will continue to monitor complaints for similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00008 |
| MDR Report Key | 3862793 |
| Report Source | 99 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-06-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMELITA TORRES |
| Manufacturer Street | 1700 A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM CHAIRSIDE WHITENING |
| Generic Name | ZOOM CHAIRSIDE WHITENING |
| Product Code | EEG |
| Date Received | 2014-06-10 |
| Lot Number | 14069020, 13203060 |
| Device Expiration Date | 2015-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-10 |