MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-07-21 for PHILIPS ZOOM ZM2666 manufactured by Discus Dental, Llc.
[50175633]
The patient stated she lost the enamel gloss of her two top front teeth (# 8 and 9 teeth), after going through zoom whitening procedure in early (b)(6) 2015. No other serious injury and damage to the body was reported to the customer. This event was reported to manufacturer on june 23rd, 2016. The kit and gel were used during the procedure, and were not returned. No specific information regarding the lot numbers used during the whitening procedure is provided at time of this report. Three potential lots were identified based on the dentist's sales history on june and july 2015. Retain samples of whitening gels from these 3 lots were tested on 7/21/2016, and results were within specifications. Device history records of these 3 kits and gels were reviewed, and no discrepancy or out of specification condition was found. Reviewed complaints history of the past 3 years. No other similar incident was reported in the past. Per clinical expert assessment, director of consumer and dental affairs, the loss of enamel gloss cannot happen due to ph of the whitening gel. Dentist stated that it seems that a dental bonding was previously applied on the patient's front tooth (# 8 tooth). No other known pre-existing condition. Based on the investigation and information provided, no malfunction, failure, or out of specification was found in the product. This incident is being reported, since the product may have caused an enamel gloss loss. Discus dental will continue to monitor complaints history for similar complaints. The whitening kit and gel were used up.
Patient Sequence No: 1, Text Type: N, H10
[50175634]
The patient stated she lost the enamel gloss of her two top front teeth (# 8 and 9 teeth), after going through zoom whitening procedure in early (b)(6) 2015. This event was reported to manufacturer on june 23rd, 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00005 |
| MDR Report Key | 5814698 |
| Report Source | CONSUMER |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-21 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2016-06-23 |
| Device Manufacturer Date | 2015-08-13 |
| Date Added to Maude | 2016-07-21 |
| 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 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 | 2016-07-21 |
| Model Number | ZM2666 |
| 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 | 2016-07-21 |