MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for BLU-U (BLUE LIGHT PHOTODYNAMIC THERAPY III) manufactured by Dusa Pharmaceuticals, Inc..
[178149649]
After levulan kerastick and blu u treatment for actinic keratoses, my face was severely burned, blistered, bleeding, and swollen so badly that i could barely open my eyes. The burning pain and constant stinging was a 10 on a pain scale from 1-10 being severe. After icing for a few days to relieve the pain, i was finally able to touch my skin in order to apply the ointments to help the healing. The physician indicated that i had a severe reaction to the medication and treatment. The mfr of the medication and blu-u need to take into consideration if a pretest can be made to determine who would benefit and who would have a severe reaction like me. The brochure does not begin to state the serious side effects that can occur. In addition, the physician needs to offer a post treatment plan to alleviate the burning, stinging, blistering pain. I was offered nothing until a week later even though i called earlier and i was given steroid ointment which hastened healing. In addition, the treatment activated my shingles. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092783 |
| MDR Report Key | 9676616 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-21 |
| Date Added to Maude | 2020-02-06 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U (BLUE LIGHT PHOTODYNAMIC THERAPY III) |
| Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
| Product Code | MVF |
| Date Received | 2020-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Brand Name | LEVULAN KERASTICK |
| Product Code | --- |
| Date Received | 2020-02-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | SUN DERMATOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |