MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-17 for ZOOM CHAIRSIDE WHITENING ZM2666 manufactured by Discus Dental, Llc.
[26070503]
An extensive investigation was conducted for (b)(4). On (b)(6) 2015, customer called stating that a patient was still experiencing sensitivity 60 days after the zoom chairside whitening procedure was performed. The investigation included review of batch history record for zm2666 zoom ch kit dw 14% tu 2pk na lot # 15142012 (chairside gel 22-3764 lot # 15133017). The review of the batch history record did not uncover any oos condition or adverse finding. In addition, the retain sample for sku # 22-3764 lot #15133017 was tested and it was found to be within specifications. No other quality issue was revealed during the review of said records. Also reviewed customer complaint log from 04/2013 to 09/2015. No similar complaints have been reported. A review of the directions for use (dfu) shows the following statement in the dfu: improper isolation may result in burning of the gingiva or swollen lips due to uv light coming in contact with tissue or chemical burn due to whitening gel coming in contact with tissue. Patients more susceptible to sensitivity are those with: known hypersensitivity, untreated caries, exposed root surfaces, defective restorations, oral tissue injury, untreated periodontal disease. It also states: treat for sensitivity it is recommended to prescribe the following prior to the procedure: 5000 ppm fluoridex daily defense sensitivity relief with 5% kno3. Instruct use of 2x/day, 14 days prior 600mg of ibuprofen 1 hour prior trays with relief acp 10-30 minutes prior for extra sensitive patients based on the investigation and information provided, it appears that the dentist did not follow the complete sensitivity protocol as stated in the dfu for this cosmetic procedure. Since the sensitivity lasted more than 60 days, this event will be reported to the fda. Discus dental will continue to monitor similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[26070504]
One patient was experiencing sensitivity 60 days after the zoom chairside whitening procedure was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2015-00003 |
| MDR Report Key | 5084416 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-08-18 |
| Date Mfgr Received | 2015-08-18 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2015-09-17 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANJAY PATEL |
| Manufacturer Street | 1700 A S BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703500 |
| Manufacturer G1 | DISCUS DENTAL, LLC |
| Manufacturer Street | 1700 A SOUTH BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM CHAIRSIDE WHITENING |
| Generic Name | ZOOM CHAIRSIDE KIT |
| Product Code | EEG |
| Date Received | 2015-09-17 |
| Model Number | ZM2666 |
| Lot Number | 15142012 |
| Device Expiration Date | 2016-08-01 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | 1700 A SOUTH BAKER AVE ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-17 |