MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR UNK manufactured by Dusa Pharmaceuticals, Inc..
| Report Number | MW5090163 |
| MDR Report Key | 9146283 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-08-25 |
| Date of Event | 2019-02-02 |
| Date Added to Maude | 2019-10-02 |
| 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 | 0 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic Name | SYSTEM, LASER PHOTODYNAMIC THERAPY |
| Product Code | MVF |
| Date Received | 2019-10-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-10-01 |