MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-09 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR BLU-U 10K 4170 manufactured by Dusa Pharmaceuticals, Inc..
[16086353]
A (b)(6) female patient received treatment for actinic keratoses with levulan kerastick and blu-u blue light photodynamic therapy illuminator consisting of a skin preparation with cerave cleanser and water, followed by application of levulan kerastick to the entire face, incubation of 1 hour, followed by 16 minutes 40 seconds of exposure to blu-u light. Patient has a history of melanoma and actinic keratoses and is on wellbutrin for anxiety and depression. Two days post treatment the patient reported to her physician that she had blisters, itching and skin tightness. The physician told her to apply specific topicals for relief. The patient reported the following monday (3 days after levulan/blu-u treatment (b)(6) 2014) that the blisters had resolved, but her skin was still tight to which the physician suggested vaseline/domeboro soaks. That night ((b)(6) 2014) the patient reported she had a seizure. Ems was called who evaluated the patient but did not transport her to the hospital. Later than evening the patient reported having another seizure/event and was taken to the emergency room. The patient's dermatologist reported that the emergency room physician stated the wellbutrin cause the seizure activity. It is the opinion of the company's chief medical officer that the wellbutrin caused the seizure and the event was not related to the levulan kerastick/blu-u treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2014-00002 |
| MDR Report Key | 3807966 |
| Report Source | 05 |
| Date Received | 2014-05-09 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-04-14 |
| Date Mfgr Received | 2014-04-15 |
| Device Manufacturer Date | 2012-11-13 |
| Date Added to Maude | 2014-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOANNE LAVALLE |
| Manufacturer Street | 25 UPTON DR. |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal | 01887 |
| Manufacturer Phone | 9789092281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic Name | BLU-U |
| Product Code | MVF |
| Date Received | 2014-05-09 |
| Model Number | BLU-U 10K |
| Catalog Number | 4170 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | WILMINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-09 |