MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-24 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[45818596]
Discus dental received a complaint on (b)(6) 2016, in which patient experienced sensitivity and pain during a zoom teeth whitening procedure. The dentist prescribed motrin and vicodin to relieve the pain. After receiving this report, retain sample of whitening gel, lot: 15168013, was tested and the results were within specifications. The gel and kit were used during the procedure, and were not returned. Device history record of whitening gel sku: 22-3764, lot: 15168013 and whitening kit sku: zm2666 lot: 15189003 were also reviewed, and no out of specifications or discrepancy was found. Reviewed complaint history. No other similar complaints were received with the same lot numbers. During investigation, it was found that the dental office did not make a tray for the patient prior to the procedure as described in dfu. Trays with relief acp can treat sensitivity and pain. Dfu is adequate. Pre-treatment and post treatment for sensitivity relief are described in dfu. No corrective action is required. Discus dental will continue to monitor the trend of similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[45818597]
Discus dental received a complaint on (b)(6) 2016, in which patient experienced sensitivity and pain after the first session of a teeth whitening procedure. The dentist prescribed motrin and vicodin to relieve the pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00004 |
| MDR Report Key | 5676525 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2015-06-26 |
| Date Added to Maude | 2016-05-24 |
| 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 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 | 2016-05-24 |
| Model Number | 22-3764 |
| Lot Number | 15168013 |
| Device Expiration Date | 2016-11-05 |
| Operator | DENTIST |
| 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 | 2016-05-24 |