MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-19 for BLU-U LIGHT TREATMENT manufactured by Dusa Pharmaceuticals.
[20655255]
Had treatment for actinic keratoses, light therapy was very painful. Six days after treatment was still having extreme pain. Redness and swelling was intense. Went back to doctor, was put on antibiotics and pain meds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035095 |
| MDR Report Key | 3695427 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-03-11 |
| Date Added to Maude | 2014-03-25 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U LIGHT TREATMENT |
| Generic Name | BLU-U LIGHT TREATMENT |
| Product Code | MVF |
| Date Received | 2014-03-19 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-03-19 |