MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-09 for ZOOM WHITENING LAMP ZM3000 manufactured by Discus Dental, Llc.
[20699812]
The dental clinic called and stated that the patient experienced burning sensation on tongue after zoom whitening procedure. The caller indicated that the patient did not want the dental chair to be reclined even after it was explained that there is a possibility that the saliva will build up. During the whitening procedure, the patient kept pushing the tongue out causing movement of the materials in the mouth. Towards the last 15 minutes, the patient pushed the tongue out and had a burning sensation. Patient left without complaining but called the next day with a blister on the tongue.
Patient Sequence No: 1, Text Type: D, B5
[20874683]
An extensive investigation was conducted for complaint # (b)(4). The investigation included review of the batch history records for the sku # 22-3764 lot # 14083035. The review of the batch history records did not uncover any adverse finding. In addition, the retain sample for sku # 22-3764 lot # 14083035 was tested and was found to be within specifications. No returned sample was received from the customer. No other quality issues were revealed during the review of the said records. The investigation also included a review of the device history record for the zoom whitespeed lamp, zm3000 serial # (b)(4) and was found to be within manufacturing specifications at the time of shipment. The review of the device history record did not uncover any adverse finding. Discus dental will continue to monitor similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00010 |
| MDR Report Key | 3927369 |
| Report Source | 05 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-05-14 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2014-07-11 |
| 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 | 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 | 1700A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM WHITENING LAMP |
| Generic Name | ZOOM LAMP |
| Product Code | EEG |
| Date Received | 2014-07-09 |
| Model Number | ZM3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-07-09 |