MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-12-13 for PHILIPS ZOOM 881055701540 manufactured by Discus Dental, Llc.
[94729492]
Discus dental received a complaint on (b)(6) 2017 in which patient experienced swollen lips after in-office zoom teeth whitening procedure. Patient visited urgent care after the incident. No additional information was provided. Investigation: - the retain sample of the in-office whitening gel, sku: 22-3764, lot: 17297005 was tested on (b)(6) 2017 and results were within specifications. - reviewed device history records of zoom whitening kit, sku: 881055701540, lot: 17299012, and whitening gel, sku: 22-3764, lot: 17297005 and no out of specification or discrepancy was found in the records. - reviewed complaints history, no other similar incidents were reported with the same lot numbers. - based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device. Potential causes may be improper lips isolation prior to the procedure or improper alignment of the lamp with the lip retractor. Zoom in-office dfu is adequate and it describes the warnings and precautions and steps for proper lip isolation and alignment of the lamp with the retractor. Based on the investigation results, no product failure and out of specification was found. Dfu is adequate and no corrective action is needed. Product was used up during the procedure
Patient Sequence No: 1, Text Type: N, H10
[94729493]
Discus dental received a complaint on (b)(6) 2017 in which patient experienced swollen lips after in-office zoom teeth whitening procedure. Patient visited urgent care after the incident. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00011 |
| MDR Report Key | 7113581 |
| Report Source | OTHER |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2017-10-30 |
| Date Added to Maude | 2017-12-13 |
| 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 SOUTH 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 |
| Product Code | EEG |
| Date Received | 2017-12-13 |
| Model Number | 881055701540 |
| Lot Number | 17299012 |
| Device Expiration Date | 2019-02-23 |
| 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 | 2017-12-13 |