MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-29 for ZOOM manufactured by Discus Dental Llc.
[1981561]
Extreme lip swelling/burn and disfigured appearance post zoom teeth - whitening procedure performed approximately between the hours of 1145-130pm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020475 |
| MDR Report Key | 2078666 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-04-29 |
| Date of Event | 2011-04-28 |
| Date Added to Maude | 2011-05-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM |
| Generic Name | ZOOM |
| Product Code | EEG |
| Date Received | 2011-04-29 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL LLC |
| Manufacturer Address | 1700 A SOUTH BALOR AVE ONTARIO, CA 91761 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-29 |