MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-25 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.
[109357474]
Discus dental received a complaint on 04/27/2018 in which patient experienced swollen lips after in-office zoom teeth whitening procedure. Dentist stated that he used a winged retractor and not the retractor provided with the zoom chairside kit. Patient has been icing lip and took benadryl. Dentist stated that the patient visited a physician and received medication, however, the patient did not disclose the type of medication. Investigation: - the retain sample of the in-office whitening gel, sku: (b)(4), lot: 18093003 was tested on 04/27/2018 and results were within specifications. - 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. Based on the information provided by the dentist, potential causes may be not using the retractor provided with the chairside whitening kit. Zoom in-office dfu is adequate and it describes the warnings and precautions, steps for proper lip isolation, and the necessity to use the isoprep retractor provided with the kit. 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
[109357475]
Discus dental received a complaint on (b)(6) 2018 in which patient experienced swollen lips after in-office zoom teeth whitening procedure. Dentist stated that he used a winged retractor and not the retractor provided with the zoom chairside kit. Patient has been icing lip and took benadryl. Dentist stated that the patient visited a physician and received medication, however, the patient did not disclose the type of medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2018-00002 |
| MDR Report Key | 7546497 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2018-05-25 |
| 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 | 2018-05-25 |
| Model Number | 881055601540 |
| Lot Number | 18096010 |
| Device Expiration Date | 2020-01-03 |
| 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 | 2018-05-25 |