MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-30 for ZOOM CHAIRSIDE WHITENING KIT ZOOM AP manufactured by Discus Dental Llc.
[4074412]
The customer reported that a patient developed swollen red lips after a whitening procedure. Looked like burns. Patient sought medical help. The doctor said patient had second degree burns.
Patient Sequence No: 1, Text Type: D, B5
[11438190]
The investigation included review of the batch history records for the sky # 22-3764 lot # 13140026. The review of the batch history records did not uncover any adverse finding. In addition, the retain sample for sku # 22-3764 lot # 13140026 was tested and was found to be within specifications. Returned sample was rec'd from the customer and was sent to the qc lab for testing but there was not enough sample to perform the required testing. 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 ap lamp, 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2013-00007 |
| MDR Report Key | 3576811 |
| Report Source | 05 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-10-31 |
| Date Mfgr Received | 2013-10-31 |
| Device Manufacturer Date | 2013-05-17 |
| Date Added to Maude | 2014-02-21 |
| 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, SR MGR |
| Manufacturer Street | 1700 A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM CHAIRSIDE WHITENING KIT |
| Generic Name | NA |
| Product Code | EEG |
| Date Received | 2013-12-30 |
| Model Number | ZOOM AP |
| 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 | 2013-12-30 |