MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-07-22 for PHILIPS ZOOM ZM2665 manufactured by Discus Dental, Llc.
[50291861]
The patient went through a zoom teeth whitening procedure at dental office on (b)(6) 2016. The patient reported this incident on (b)(6) 2016, and described she suffered severe swelling, second degree burns, blistering, and bleeding lips. The patient stated that she was not able to go to work for two weeks, and she visited medical doctors for treatments. She was prescribed antibiotic topical gel and steroid cream. Device history records of (b)(4) zoom whitening gel, lot # 15343006 and zm2665 zoom whitening kit, lot # 15337007 were reviewed. The review of the device history records did not uncover any out of specification condition or adverse finding. In addition, the retain sample of the whitening gel, lot # 15343006 was tested on 06/29/2016. The results were within specifications. No other quality issue was found during the review of the records. Customer complaint log from (b)(6) 2015 to (b)(6) 2016 was reviewed. No other safety incident was reported with the same lot numbers. Labeling and direction for use were reviewed. The dfu is adequate, and it describes precautions, isolation, whitening procedure, and steps to sooth tissue. Based on the investigation and information available, no malfunction, failure, or out of specification was found in the product. Improper isolation prior to the procedure may have caused this event. Discus dental will continue to monitor complaints. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[50291862]
The patient went through a zoom teeth whitening procedure at dental office on (b)(6) 2016. The patient reported this incident on (b)(6) 2016, and described she suffered severe swelling, second degree burns, blistering, and bleeding lips. The patient stated that she was not able to go to work for two weeks, and she visited medical doctors for treatments. She was prescribed antibiotic topical gel and steroid cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2016-00006 |
| MDR Report Key | 5817608 |
| Report Source | CONSUMER |
| Date Received | 2016-07-22 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-06-24 |
| Device Manufacturer Date | 2015-11-23 |
| Date Added to Maude | 2016-07-22 |
| 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 | 9095703537 |
| 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 | 2016-07-22 |
| Model Number | ZM2665 |
| Lot Number | 15337007 |
| Device Expiration Date | 2017-01-28 |
| 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 | 2016-07-22 |