MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (LEVULAN KERASTICK AND BLU-U PDT) manufactured by Dusa Pharmaceuticals.
[96848845]
I have been severely burned as a result of photodynamic therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074456 |
| MDR Report Key | 7174535 |
| Date Received | 2018-01-08 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-01-02 |
| Date Added to Maude | 2018-01-09 |
| 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 | BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (LEVULAN KERASTICK AND BLU-U PDT) |
| Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
| Product Code | MVF |
| Date Received | 2018-01-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2018-01-08 |