MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-21 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.
[80753158]
Discus dental received a complaint on (b)(6) 2017, in which patient initially experienced pain during zoom in-office teeth whitening procedure. Ten minutes later, hives appeared on patient's face, back and arms. Steroids were prescribed by the medical doctor. The patient was feeling better 2 days after the event and was healed one week after the incident. Investigation: the kit and gel were used up during the procedure and were not returned. Reviewed complaints history, no other similar incident was reported from the same lot numbers. Reviewed the device/batch history records of gel, sku: (b)(4), lot: 17030021, zoom whitening kit, sku: (b)(4), lot: 17040011, udi: (b)(4), and zoom whitespeed lamp, sku: (b)(4), sn: (b)(4). No out of specification or discrepancy was found. The retain sample of the whitening gel, sku: (b)(4), lot: 17030021, was tested on 07/20/2017, and results were within specifications. Reviewed direction for use of the kit. The dfu describes candidate qualification, warnings, ingredients, treat for tooth sensitivity, and other precautions. A potential cause for hives breakout would be an allergic reaction to one of the product ingredients. In addition, as described in dfu, pre-existing tooth sensitivity may have contributed to the pain and sensitivity experienced during the procedure. Based on the investigation results and available information, discus dental concludes there was no product failure or malfunction. The whitening kit and gel were used up.
Patient Sequence No: 1, Text Type: N, H10
[80753159]
Discuss dental received a complaint on (b)(6) 2017, in which patient initially experienced pain during zoom in-office teeth whitening procedure. Ten minutes later, hives appeared on patient's face, back and arms. Steroids were prescribed by the medical doctor. The patient was feeling better 2 days after the event, and was healed one week after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00007 |
| MDR Report Key | 6734079 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2017-02-13 |
| Date Added to Maude | 2017-07-21 |
| 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 | 2017-07-21 |
| Model Number | 881055601540 |
| Lot Number | 17040011 |
| Device Expiration Date | 2018-12-05 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-07-21 |