MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-07 for PHILIPS ZOOM 22-3764 manufactured by Discus Dental, Llc.
[135456895]
Discus dental received a complaint on (b)(6) 2019, in which the patient experienced severe pain after the third session of the in-office chairside teeth whitening procedure. Office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen. Office called back saying the pain did not go away and seemed to be worse. Pain and sensitivity is a common side effect of the zoom in-office chairside teeth whitening procedure. However, since the cosmetic procedure uses zoom2 advanced power lamp (class i device) and relief acp (class ii device) was used to treat sensitivity, this incident is being reported to fda. No impact on shipped products from the same lot and no similar complaint from the lot of cosmetic gel. No containment action is required. The kit and gel were used up during the procedure and were not returned. The retain sample of the teeth whitening gel, sku: 22-3764, lot: 18165002, was tested on 01/17/2019, and results were within specifications. Reviewed the device/batch history records of zoom! Teeth whitening kit, sku: 881055601540, lot: 18165003 and gel, sku: 22-3764, lot: 18165002. No out of specification or discrepancy was found. Reviewed deviation and ncmr records of zoom2 advanced power lamp and no out of specification or discrepancy was found. Reviewed complaints history, no other similar incident was reported from the same lot numbers. Reviewed direction for use of the kit. The dfu describes steps for candidate qualification, warnings, ingredients, treatment for sensitivity and other precautions. No product failure or out of specifications was found in the product. Potential cause may be due to a pre-existing sensitivity. Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product. No corrective actions are required.
Patient Sequence No: 1, Text Type: N, H10
[135456896]
Discus dental received a complaint on (b)(6) 2019, in which the patient experienced severe pain after the third session of the in-office teeth whitening cosmetic procedure. Dental office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen. Office called back saying the pain did not go away and seemed to be worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2019-00001 |
| MDR Report Key | 8318343 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2019-02-07 |
| 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 | FRANCES ESTRADA |
| Manufacturer Street | 1700A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703542 |
| 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 KIT |
| Product Code | EEG |
| Date Received | 2019-02-07 |
| Model Number | 22-3764 |
| Lot Number | 18165002 |
| Device Expiration Date | 2019-11-23 |
| 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 | 1700A SOUTH BAKER AVE. ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |