MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-09 for ZOOM AP LAMP ZOOM AP 2.5 manufactured by Discus Dental, Llc.
[19804859]
An extensive investigation was conducted for complaint # (b)(4). On (b)(6) 2014, (b)(6) called to report that they had an injury during a zoom whitening procedure. They stated that pt kept moving causing the gel to burn lip. After completing the zoom teeth whitening procedure, the pt complained of very sensitive teeth and swollen lip. The pt ended up getting a 3rd degree burn inside the mouth on the right side. The pt's right side of the neck including the glands was swollen for a day. The pt went to the emergency room and was given antibiotic and pain pills.
Patient Sequence No: 1, Text Type: D, B5
[19820461]
The investigation included review of the batch history records for the sku # 22-3764, lot # 13245045. The review of the batch history records did not uncover any adverse finding. In addition, the retain sample for sku # 22-3764, lot # 13245045 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 device history record for the zoom ap lamp, zm2550, serial # (b)(4) is not available for review since the lamp was manufactured in 2006 and the record retention for the dhr is five years. Based on the results of the investigation and the info provided, it appears that the incident happened due to the pt's movement during the procedure potentially exposing the pt's inside of the mouth and lips to the whitening gel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00012 |
| MDR Report Key | 3927393 |
| Report Source | 04 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-05-16 |
| Device Manufacturer Date | 2006-01-01 |
| 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 | 0 |
| 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 |
| Manufacturer Phone | 9095703512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM AP LAMP |
| Generic Name | ZOOM AP LAMP |
| Product Code | EEG |
| Date Received | 2014-07-09 |
| Model Number | ZOOM AP 2.5 |
| 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 |