MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-06 for PHILIPS ZOOM manufactured by Discus Dental, Llc.
[72073986]
Discus dental received a complaint on 03/09/2017, in which the patient experienced swelling, pain, and irritation of lip and gingiva 2 days after the in-office zoom teeth whitening procedure. The swelling was minor, and the patient was prescribed antibiotics. No additional information regarding medical treatments was reported. Investigation: the kit and gel were used up during the procedure and were not returned. The retain sample of the whitening gel, sku: 22-3764, lot: 16335009, was tested on 03/13/2017, and results were within specifications. Reviewed the device/batch history records of whitening kit, sku: zm2666, lot: 15323032, and gel, sku: 22-3764, lot: 16335009 were reviewed. No out of specification or discrepancy was found. Reviewed complaints history of the last 2 years, no other similar incident was reported from the same lots. Reviewed direction for use of the kit. The dfu describes steps for tissue isolation, candidate qualification, warnings, and other precautions. Upon review of the device history record of whitening kit, sku: zm2666, lot: 15323032, it was noticed that the expiration date of the kit was on 01/19/2017, while the procedure was performed on (b)(6) 2017. The dhr and bill of material confirm that the expiration date was included on the product labeling. Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product. No corrective actions are required. Failure to follow the instructions provided with the product and use of an expired kit, or any pre-existing medical condition of the patient may have contributed to this adverse event. Discus dental will continue to monitor similar complaints. The whitening kit and gel were used up.
Patient Sequence No: 1, Text Type: N, H10
[72073987]
Discus dental received a complaint on 03/09/2017, in which the patient experienced swelling, pain, and irritation of lip and gingiva 2 days after the in-office zoom teeth whitening procedure. The patient was prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00004 |
| MDR Report Key | 6470605 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-06 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2015-11-20 |
| Date Added to Maude | 2017-04-06 |
| 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 | 2017-04-06 |
| 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 | 2017-04-06 |