MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-05 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[74584681]
Discus dental received a complaint on 04/10/2017, in which patient claimed in-office tooth whitening procedure caused sensitivity and a crack on occlusal surface on (b)(6) 2016. The tooth was extracted on (b)(6) 2017. The patient took amoxicillin as a medication. Reviewed complaints history of the past 3 years. No similar incident was reported. Per clinical expert assessment, no occlusal surface should be affected during the chairside whitening procedure if dfu is followed. Chairside whitening is advised on healthy teeth and it is rare for a healthy tooth to crack or chip due to a whitening procedure. Although, unless there was an undiagnosed crack or chip unrelated to the whitening, and the whitening gel exacerbated the pain and sensitivity which made the patient and dentist notice the crack on the tooth. No corrective actions are required. Dfu is adequate and it describes candidate qualification, safety directions, warnings, and precautions. Dfu states to disqualify any patient who is perio-involved, exhibits failing restorations or is otherwise in an unhealthy oral state. It also describes patients more susceptible to sensitivity are those with known hypersensitivity, untreated caries, exposed root surfaces, defective restorations, oral tissue injury, and untreated periodontal disease. With the available information, discus dental is unable to confirm the complaint and to determine the cause. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[74584682]
Discus dental received a complaint on (b)(6) 2017, in which patient claimed in-office tooth whitening procedure caused tooth sensitivity and a crack on occlusal surface on (b)(6) 2016. The tooth was extracted on (b)(6) 2017. The patient took amoxicillin as a medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00005 |
| MDR Report Key | 6549769 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-05 |
| Date of Report | 2017-05-05 |
| Date of Event | 2016-11-29 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-05-05 |
| 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 | 9095703508 |
| 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 | PHILIPS ZOOM |
| Generic Name | ZOOM CHAIRSIDE WHITENING KIT AND GEL |
| Product Code | EEG |
| Date Received | 2017-05-05 |
| Model Number | 22-3764 |
| 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. Deathisabilit | 2017-05-05 |