MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-10 for ZOOM AP CHAIRSIDE WHITENING manufactured by Discus Dental, Llc.
[4457519]
On (b)(6) 2014, the office reported that they did a zoom procedure on a patient and the patient's gum area between 8 & 9 turned black and puffy. Dentist had the patient use antiseptic rinse. Patient is now fine.
Patient Sequence No: 1, Text Type: D, B5
[12162092]
An extensive investigation was conducted for complaint # (b)(4). On (b)(6) 2014, the office reported that they did a zoom procedure on a patient and the patient's gum area between 8 & 9 turned black and puffy. Dentist had the patient use antiseptic rinse. Patient is now fine. The investigation included review of bath history record for zm2665 zoom ch kit lot #14052001 (chairside gel 22-3764 lot #14048021). In addition, the retain sample for sku (b)(4), lot #14048021 was tested and it was found to be within specifications. No other quality issue was revealed during the reviewed of said records. The device history record for the zoom ap lam, zm2501 serial # (b)(4) is not available for review since the lamp was manufactured in 2005 and the record retention for the dhr is five years. Based on the investigation, it appears that this is an isolated incident. Discus dental will continue to monitor for similar incidents.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00007 |
| MDR Report Key | 3862791 |
| Report Source | 99 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-04-25 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2014-06-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMELITA TORRES |
| Manufacturer Street | 1700 A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM AP CHAIRSIDE WHITENING |
| Generic Name | ZOOM AP CHAIRSIDE WHITENING |
| Product Code | EEG |
| Date Received | 2014-06-10 |
| Model Number | ZOOM AP |
| Lot Number | 14048021 |
| 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 | ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-10 |