MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-06 for PHILIPS ZOOM manufactured by Discus Dental, Llc.
[64133138]
Discus dental received a complaint on 12/08/2016, in which the patient stated she is still experiencing pain after an in-office zoom teeth whitening procedure performed in (b)(6) 2016. The patient experienced burn on top gums during the whitening procedure. The patient visited ear, nose and throat doctor, however she only took otc drug for the pain. No information was provided by the patient regarding product part number, lot number, or dental office contact information. During the follow up with the patient on 12/20/2016, patient stated that the pain has gotten better. No further information. - reviewed direction for use of the in-office whitening zoom chairside kit. It describes the steps for proper isolation of soft tissue to prevent burn and irritation. It also includes candidate qualification, safety directions, warnings, and precautions. - reviewed complaints history of the past year. Only one other similar incident was reported in the united states, in which the user failed to properly perform the isolation prior to the procedure. (report # 1000582314-2016-00007). With the available information, discus dental concludes there was no malfunction or failure in the product. No corrective actions are required. The potential cause of this incident can be failure to follow the instructions provided with the product. Any pre-existing medical condition of the patient may also have contributed to this adverse event. Discus dental will continue to monitor similar complaints. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[64133139]
Discus dental received a complaint on 12/08/2016, in which the patient stated she is still experiencing pain after an in-office zoom teeth whitening procedure performed in (b)(6) 2016. The patient experienced burn on top gums during the whitening procedure. The patient visited ear, nose and throat doctor, however she only took advil for the pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00001 |
| MDR Report Key | 6231372 |
| Report Source | CONSUMER |
| Date Received | 2017-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-06 |
| 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 | 2017-01-06 |
| 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 | 2017-01-06 |