MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-10 for PHILIPS ZOOM ZM2665 manufactured by Discus Dental, Llc.
[67208605]
(b)(4) received a complaint on 01/13/2017, where patient experienced sensitivity and pain during zoom chairside in-office teeth whitening procedure. The patient took vicodin, however it was not prescribed by the dentist. The patient did not visit a medical facility, and is feeling better now. Investigation after receiving this report, retain sample of the whitening gel from the same lot (lot# 16183030), was tested and the results were within specifications; the gel and kit were used during the procedure, and were not returned; device history records of whitening gel sku: 22-3764, lot: 16183030; whitening kit sku: zm2665, lot: 16161012; and whitening lamp sku: zm3000, serial number: (b)(4) were reviewed, and no out of specifications or discrepancy was found in the records; reviewed complaints history. No other similar complaints were received with the same lot numbers; reviewed instructions for use of the whitening kit. It describes candidate qualifications, step-by-step procedure, precautions, warnings, and pre-treatment and post treatment for sensitivity. Conclusion: no device failure or out of specification was found during the investigation. It can be concluded that pre-existing sensitivity or failure to follow pre-procedure steps described in dfu contributed to this experience. Dfu is adequate, and no corrective action is required. (b)(4) will continue to monitor the trend of similar complaints. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[67208606]
(b)(4) received a complaint on 01/13/2017, where patient experienced sensitivity and pain during zoom chairside in-office teeth whitening procedure. The patient took vicodin, however it was not prescribed by the dentist. The patient did not visit a medical facility, and is feeling better now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00002 |
| MDR Report Key | 6324494 |
| Report Source | CONSUMER |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-01-06 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2016-06-02 |
| Date Added to Maude | 2017-02-10 |
| 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 | 2017-02-10 |
| Model Number | ZM2665 |
| Lot Number | 16161012 |
| Device Expiration Date | 2017-06-30 |
| 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 | 2017-02-10 |