MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc, A Sun Pharma Company.
[102216030]
A patient had levulan applied, incubated properly and was positioned in the blu-u. Approximately 12 minutes into treatment the blu-u stopped working. Treatment could not be completed. Follow-up ((b)(6) 2018): follow-up by reporter. No significant information was received.
Patient Sequence No: 1, Text Type: N, H10
[102216031]
Approx 12 minutes into treatment the blu-u stopped working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00003 |
| MDR Report Key | 7329375 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-03-09 |
| 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 Street | 25 UPTON DR |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR |
| Generic Name | BLU-U |
| Product Code | MVF |
| Date Received | 2018-03-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, LNC, A SUN PHARMA COMPANY |
| Manufacturer Address | 25 UPTON DRIVE WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |