MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-03-16 for PHILIPS ZOOM ZM2665 manufactured by Discus Dental, Llc.
[40489526]
The patient went through a zoom teeth whitening procedure on (b)(6) 2016. The patient complained about swollen lips the next day, and visited urgent care on (b)(6) 2016. Benadryl was prescribed in the urgent care. The patient visited the dentist on (b)(6) 2016, and the lips were no longer swollen. The incident was reported to discus dental on (b)(6) 2016. Batch history records of (b)(4) zoom whitening gel, lot # 15210013 and (b)(4) zoom whitening kit, lot # 15217042 were 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 # 15210013 was tested on 02/18/2016. 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 safety incidents have been reported with the same lot numbers. Similar incident rate is (b)(4). (total similar incidents from 01/01/2015 to 03/01/2016 divided by total sales of zoom chairside kit in the same period). The trend is negative compare to 2014 incident rate which was (b)(4). 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. Vitamin e oil apply vitamin e oil to lips to moisturize before retraction. Tip: if patient notes irritation at margin use vitamin e oil to sooth tissue. Based on the investigation and information provided, possible allergic reaction, patient-device incompatibility, and improper isolation prior to the procedure may have contributed to this incident. Since the patient went to urgent care and took benadryl, this event will be reported to fda. Discus dental will continue to monitor similar complaints. The whitening kit was used.
Patient Sequence No: 1, Text Type: N, H10
[40489527]
The patient went through a zoom teeth whitening procedure on (b)(6) 2016. The patient complained about swollen lips the next day, and visited urgent care on (b)(6) 2016. Benadryl was prescribed in the urgent care. The patient visited the dentist on (b)(6) 2016, and the lips were no longer swollen. The incident was reported to discus dental on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00002 |
| MDR Report Key | 5504815 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-03-16 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-02-10 |
| Date Mfgr Received | 2016-02-16 |
| Device Manufacturer Date | 2015-08-13 |
| Date Added to Maude | 2016-03-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 KIT |
| Product Code | EEG |
| Date Received | 2016-03-16 |
| Model Number | ZM2665 |
| Lot Number | 15217042 |
| Device Expiration Date | 2016-07-29 |
| 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. Hospitalization | 2016-03-16 |