MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-05 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2564 manufactured by Discus Dental, Llc.
[2115933]
After the third cycle of a four cycle procedure, the patient reported, he was feeling "zingers" (tooth sensitivity), but wanted to complete the last (4th) cycle. After the 4th cycle, he continued to have sensitivity issues. Dr (b)(6) prescribed vicodin to the patient. Only treatment date was on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021286 |
| MDR Report Key | 2159093 |
| Date Received | 2011-07-05 |
| Date of Report | 2011-07-05 |
| Date of Event | 2011-06-06 |
| Date Added to Maude | 2011-07-15 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| 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 WHITENING LAMP AND PROCEDURE KIT |
| Generic Name | EEG |
| Product Code | EEG |
| Date Received | 2011-07-05 |
| Model Number | ZM2564 |
| Catalog Number | ZM2564 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | CULVER CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-05 |