MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-03-03 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[39628914]
On (b)(6) 2016, customer called stating that a patient experienced pain and sensitivity 2 hours after the zoom chairside whitening procedure was performed. The patient took rx medication (oxycodone) at home which was not prescribed to her. The patient is no longer experiencing any sensitivity or pain. Batch history record of 22-3764 zoom whitening gel, lot # 15349014 and zm2666 zoom whitening kit, lot # 15337022 was reviewed. The review of the batch history record did not uncover any out of specification condition or adverse finding. In addition, the retain sample of the whitening gel, lot # 15349014 was tested on (b)(6) 2016. The results were within specifications. No other quality issue was revealed during the review of the records. Customer complaint log from (b)(6) 2015 to (b)(6) 2016 was reviewed. No other complaints have been reported with the same lot number. Notes from directions for use (dfu) of the zoom whitening kit; precautions 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. 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, possible allergic reaction and improper isolation prior to the procedure may have contributed to this incident. Since the patient took rx medication to alleviate the pain, this event will be reported to the fda. Discus dental will continue to monitor similar complaints. The whitening gel was used.
Patient Sequence No: 1, Text Type: N, H10
[39628915]
Patient experienced slight discomfort during teeth whitening procedure. Two hours later, patient had extreme pain. The patient took rx medication (oxycodone) at home, which was not prescribed to her. She is no longer experiencing any sensitivity or pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00001 |
| MDR Report Key | 5477981 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-03-03 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-09 |
| Date Mfgr Received | 2016-02-09 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2016-03-03 |
| 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 |
| 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 | 9095703537 |
| 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 GEL |
| Product Code | EEG |
| Date Received | 2016-03-03 |
| Model Number | 22-3764 |
| Lot Number | 15349014 |
| Device Expiration Date | 2017-05-16 |
| 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 | 2016-03-03 |