MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for PHILIPS ZOOM 881071601540 manufactured by Discus Dental, Llc.
[60747420]
Discus dental received a complaint on (b)(6) 2016. The incident occurred during an in-office teeth whitening procedure performed by dental assistant. The brush applicator containing hydrogen peroxide, accidentally touched the patient's lip and caused a burn with no blisters. The dentist prescribed vicodin. The patient is healed, and is not experiencing any symptoms. The retain sample of the quickpro varnish of the same lot (sku: 8810 716 01540, lot: 16267008) was tested on 11/07/2016 and the results were within specifications. The gel and kit were used during the procedure, and were not returned. Batch history record of quickpro varnish (lot: 16267008) was reviewed, and no out of specifications, non-conformance or discrepancy was found. Reviewed complaint history. No other similar complaints were received with the same lot number. Based on the investigation results, and complaint description it can be concluded that there was no product failure or malfunction. User error and not following the procedure caused this incident. Dfu is adequate. Dfu describes the steps for applying the whitening varnish using brush, and avoiding soft tissue. It also includes warnings, safety directions, and precautions. Since quickpro whitening varnish is cosmetics and not classified as a medical device, "eif" was selected as the "product code" in section of this report. Discus dental will continue to monitor similar complaints. The whitening kit were used up.
Patient Sequence No: 1, Text Type: N, H10
[60747421]
Discus dental received a complaint on (b)(6) 2016. The incident occurred during an in-office teeth whitening procedure performed by dental assistant. The brush applicator containing hydrogen peroxide, accidentally touched the patient's lip and caused a burn with no blisters. He dentist prescribed vicodin. The patient is healed, and is not experiencing any symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00009 |
| MDR Report Key | 6123485 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2016-09-28 |
| Date Added to Maude | 2016-11-22 |
| 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 | 0 |
| Brand Name | PHILIPS ZOOM |
| Generic Name | QUICKPRO WHITENING VARNISH |
| Product Code | EIF |
| Date Received | 2016-11-22 |
| Model Number | 881071601540 |
| Lot Number | 16267008 |
| Device Expiration Date | 2017-08-28 |
| Operator | DENTAL ASSISTANT |
| 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 | 2016-11-22 |