MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for VIZILITE PRO manufactured by Den-mat Holdings Llc.
[116714194]
Hi, i went to (b)(6), for my dental appt. I got vizilite pro, oral lesion screening system to screen cancer. I am not sure if this instrument was fda/cdrh cleared / approved. Anyway, as today three days later, i still feel my tongue was burnt, not comfortable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078943 |
| MDR Report Key | 7768247 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-06 |
| Date of Event | 2001-08-03 |
| Date Added to Maude | 2018-08-09 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIZILITE PRO |
| Generic Name | VIZILITE PRO |
| Product Code | NXV |
| Date Received | 2018-08-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEN-MAT HOLDINGS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-08 |