MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for VIRULITE manufactured by Virulite Llc.
[143400642]
I used the virulite device as instructed on my upper lip twice on (b)(6) 2019 at about 9am and 7pm. I woke the next day with severe burn from the bottom of my nose to the top of my lip. My cold sore had spread across my top lip and to my bottom lip. The burn extended into my right nostril. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5086121 |
MDR Report Key | 8546304 |
Date Received | 2019-04-23 |
Date of Report | 2019-04-21 |
Date of Event | 2019-04-17 |
Date Added to Maude | 2019-04-24 |
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 | VIRULITE |
Generic Name | LIGHT BASED TREATMENT FOR COLD SORES HERPES SIMPLEX VIRUS-1 |
Product Code | OKJ |
Date Received | 2019-04-23 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | VIRULITE LLC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-04-23 |