MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for BLUE LIGHT-PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170 manufactured by Dusa Pharmaceuticals, Inc..
[144850863]
Had levulan kerastick +blu-u. Blue light photodynamic therapy illuminator model 4170 treatment. At advanced dermatology and cosmetic surgery, in the (b)(6). I was under the blue light for 4 mins. My face started burning immediately and the little fan they gave to use was only able to help slightly. They then sprayed water on my face to help cool it. Within a couple mins my face felt like the blood was boiling under my skin. I had them stop the treatment and went home. I was unable to sleep for two days because of the pain. My face was bleeding in several places, and it took 6 days for the pain to subside. I have a picture of the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086528 |
| MDR Report Key | 8599968 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-29 |
| Date Added to Maude | 2019-05-10 |
| 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 | BLUE LIGHT-PHOTODYNAMIC THERAPY ILLUMINATOR MODEL 4170 |
| Generic Name | SYSTEM, LASER, PHOTOGYNAMIC THERAPY |
| Product Code | MVF |
| Date Received | 2019-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |