MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-07-03 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[79027076]
(b)(6) dental received a complaint on (b)(6) 2017, in which patient experienced a pain during zoom in-office whitening procedure, and a possible allergic reaction in the same day at home after the procedure on (b)(6) 2017. The patient's throat closed, lost his voice and experienced runny nose. The family doctor prescribed antibiotics. Investigation: the retain sample of the whitening gel, sku: 22-3764, lot: 17040004, was tested on (b)(6) 2017, and results were within specifications. Reviewed the device/batch history records of gel, sku: 22-3764, lot: 17040004, zoom whitening kit, sku: 881055601540, lot: 17020028, (b)(4), and zoom whitespeed lamp, sku: zm3000, sn: (b)(4). No out of specification or discrepancy was found. Reviewed complaints history, no other similar incident was reported from the same lot numbers. The kit and gel were used up during the procedure and were not returned. Reviewed direction for use of the kit. The dfu describes candidate qualification, warnings, ingredients, and other precautions. Potential cause may be an allergic reaction to one of the product ingredients. Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product. (b)(4). The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[79027077]
(b)(6) dental received a complaint on (b)(6) 2017, in which patient experienced a pain during zoom in-office whitening procedure, and a possible allergic reaction in the same day at home after the procedure on (b)(6) 2017. The patient's throat closed, lost his voice and experienced runny nose. The family doctor prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00006 |
| MDR Report Key | 6685182 |
| Report Source | CONSUMER |
| Date Received | 2017-07-03 |
| Date of Report | 2017-07-03 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-07-03 |
| 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 | 2017-07-03 |
| Model Number | 22-3764 |
| Lot Number | 17040004 |
| Device Expiration Date | 2018-07-16 |
| 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 | 2017-07-03 |