MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-08-22 for PHILIPS ZOOM ZM2666 manufactured by Discus Dental, Llc.
[52721099]
The incident was occurred in (b)(6). Thus gel and kit were used, and not available to be returned. The retain samples of whitening gels from the same lots were tested on (b)(6) 2016, and results were within specifications. Device history record of whitening gel and whitening kit were reviewed, and no out of specifications or discrepancy was found. Reviewed the bill of materials and instructions for use. Dfu describes the steps for proper isolation of gums and lips. Warning notes are also included in the product packaging. Reviewed complaints history of the past 3 years, and no other similar complaints were received with similar symptoms. Discus dental concludes that no malfunction or failure is detected in the device. The cause of this incident, as described in complaint description, is failure to follow the instructions provided with the product. Discus dental will continue to monitor similar complaints. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[52721100]
Discus dental received the complaint on 7/25/2016, in which the patient received a zoom in-office whitening procedure in (b)(6) 2016. The hygienist who performed the whitening did not follow the whitening protocol, and did not cover the patient's gingiva. Thereafter the patient experienced swollen gums. The patient visited a doctor, and they performed colonoscopies, and prescribed vicodin and motrin. The patient is also experiencing bone density loss in the same area where the gums were swollen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00007 |
| MDR Report Key | 5895310 |
| Report Source | CONSUMER |
| Date Received | 2016-08-22 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-07-25 |
| Device Manufacturer Date | 2015-06-26 |
| Date Added to Maude | 2016-08-22 |
| 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 | 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 | 2016-08-22 |
| Model Number | ZM2666 |
| Lot Number | 15196003 |
| Device Expiration Date | 2016-08-31 |
| 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 | 2016-08-22 |