MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-22 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[60744857]
Discus dental received a complaint on 10/25/2016. The patient completed in-office teeth whitening procedure, and since then she is experiencing tooth lingering sensitivity. The patient visited a specialist for evaluation, who found nothing wrong. After receiving this report, retain sample of the whitening gel, lot: 15232022, was tested and the results were within specifications. The gel and kit were used during the procedure, and were not returned. Batch history record of whitening gel sku: 22-3764, lot: 15232022 was reviewed, and no out of specifications, non-conformance or discrepancy was found. Reviewed complaint history. No other complaints were received with the same lot number. Based on the investigation results, no product failure or malfunction was detected. Dental office informed that the patient had scaling and root planning (srp) one month before the whitening procedure. With the available information, it can be concluded that, pre-existing sensitivity may have contributed to the lingering teeth sensitivity. It is also plausible that scaling and root planning prior to the whitening might have enhanced the sensitivity experience. Dfu is adequate. Pre-treatment and post treatment for sensitivity are described in dfu. No corrective action is required. It also includes warnings, precautions, and candidate qualification. Discus dental will continue to monitor similar complaints. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[60744858]
Discus dental received a complaint on 10/25/2016. The patient completed in-office teeth whitening procedure, and since then, she is experiencing tooth lingering sensitivity. The patient visited a specialist for evaluation, who found nothing wrong.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00008 |
| MDR Report Key | 6123486 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2015-08-25 |
| 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 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 2016-11-22 |
| Model Number | 22-3764 |
| Lot Number | 15232022 |
| Device Expiration Date | 2017-01-07 |
| Operator | DENTIST |
| 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 |