MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-11 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[44999052]
After receiving this report, retain sample of whitening gel, lot: 15182013, was tested and the results were within specifications. The gel and kit were used during the procedure, and were not returned. Device history record of whitening gel (lot: 15182013) and whitening kit (lot: 15189005) were also reviewed, and no out of specifications and discrepancy was found. No other similar complaints were received with the same lot numbers. There was also no other injury report received with the same symptoms. Based on the complaint history overall rate for all allergic reaction since 2014 is less than (b)(4)% compare to sales. After the follow-up with the dentist on (b)(6) 2016, it was found that the patient fully recovered after the treatments. The dentist also commented "the patient admitted to being allergic to virtually everything". No corrective action is required. The dfu of the kit recommends to provide the ingredient label to the patient, and also describes candidate qualification.
Patient Sequence No: 1, Text Type: N, H10
[44999053]
Discus dental received a complaint on (b)(6) 2016, in which patient had an allergic reaction during a zoom teeth whitening procedure which was performed by a dental hygienist. The patient experienced severe pain during the procedure. It followed with high blood pressure, and shaking and numbness in her hands. The dentist administer nitrous oxide/oxygen, numbed her lower jaw with lidocaine, and injected epipen to her thigh. There was no sign of burned or swollen body tissue. The patient was taken to the emergency room by an ambulance. The patient was diagnosed with vaso-vagal at the hospital. The patient fully recovered after the treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00003 |
| MDR Report Key | 5648639 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-11 |
| Date of Report | 2016-05-11 |
| Date of Event | 2016-04-22 |
| Date Mfgr Received | 2016-04-22 |
| Device Manufacturer Date | 2015-06-26 |
| Date Added to Maude | 2016-05-11 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 2016-05-11 |
| Model Number | 22-3764 |
| Lot Number | 15182013 |
| Device Expiration Date | 2016-12-10 |
| Operator | DENTAL HYGIENIST |
| 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. Hospitalization | 2016-05-11 |