MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for PHILIPS ZOOM 881071601540 manufactured by Discus Dental, Llc.
[71579495]
Discus dental received a complaint on 03/06/2017. The incident occurred during an in-office teeth whitening procedure performed by the dental hygienist. The patient claimed the procedure wasn't done correctly. The liquidam was not appropriately applied, and a large amount of gel was applied instead of painted. She felt burning as soon as the whitening gel was applied. The patient visited her doctor after the incident, and she is using fluoride paste. No other information regarding medical treatment was reported. Investigation: the retain sample of the quickpro varnish of the same lot (sku: 8810 716 01540, lot: 16351011) was tested on 03/07/2017 and the results were within specifications. The whitening kit was used during the procedure and was not returned to the manufacturer. Batch history record of quickpro varnish (lot: 16351011) was reviewed, and no out of specifications, or non-conformance 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. Based on the information provided by the patient, it can be concluded that the dental hygienist did not follow the procedure as described in the dfu. Dfu is adequate. Dfu describes the steps for isolating gums using liquidam, applying the whitening gel using the brush, and avoiding soft tissue. It also includes warnings, safety directions, and precautions. Since quickpro whitening varnish is cosmetic and not classified as a medical device, "eie" was selected as the "product code". Discus dental will continue to monitor similar complaints. The whitening kit was used up.
Patient Sequence No: 1, Text Type: N, H10
[71579496]
Discus dental received a complaint on 03/06/2017. The incident occurred during an in-office teeth whitening procedure performed by the dental hygienist. The patient claimed the procedure wasn't done correctly. The liquidam was not appropriately applied, and a large amount of gel was applied instead of painted. She felt burning as soon as the whitening gel was applied. The patient visited her doctor after the incident, and she is using fluoride paste. No other information regarding medical treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00003 |
| MDR Report Key | 6455651 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 2016-12-14 |
| Date Added to Maude | 2017-04-03 |
| 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 | 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 | EIE |
| Date Received | 2017-04-03 |
| Model Number | 881071601540 |
| Lot Number | 16351011 |
| Device Expiration Date | 2017-11-11 |
| 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 | 2017-04-03 |