MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-04 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.
[88207686]
Discus dental received a complaint on (b)(6) 2017 in which patient had an allergic reaction and broke out in hives during in-office teeth whitening procedure. No pain or injury in the mouth or lips was reported. The patient took benadryl and was referred to see an allergist by her dentist. No information was provided if the patient visited a specialist or not. The dentist mentioned that the patient appeared itchy and uncomfortable before starting the procedure. The hives were cleared up within the next day. Investigation: - the product was used up during the procedure and not available for return. - the retain sample of the zoom whitening gel, (b)(4), lot: 17158007 was tested on 9/13/2017 and results were within specifications. - reviewed device history records of zoom whitening kit, (b)(4), lot: 17131017, zoom whitening gel, (b)(4), lot: 17158007 and no out of specification was found in the records. - reviewed receiving records and certificate of analysis of liquidam and no out of specification was found. - reviewed complaints history, no other similar incidents were reported from the same lots. - reviewed direction for use of the kit. The dfu describes candidate qualification, warnings, ingredients, and other precautions. Product labeling also includes ingredients list. - potential cause of this event 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. Product was used up during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[88207687]
Discus dental received a complaint on (b)(6) 2017 in which patient had an allergic reaction and broke out in hives during in-office teeth whitening procedure. No pain or injury in the mouth or lips was reported. The patient took benadryl and was referred to see an allergist by her dentist. No information was provided if the patient visited a specialist or not. The dentist mentioned that the patient appeared itchy and uncomfortable before starting the procedure. The hives were cleared up within the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00008 |
| MDR Report Key | 6914176 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-04 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2017-10-04 |
| 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 AND GEL |
| Product Code | EEG |
| Date Received | 2017-10-04 |
| Model Number | 881055601540 |
| Lot Number | 17131017 |
| Device Expiration Date | 2019-03-14 |
| 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 | 2017-10-04 |