MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc..
[103555922]
Patient had "blue light treatment" to face two hours after receiving levulan kerastick application. Fifteen minutes later patient received a second "blue light treatment" to scalp. Patient also reported it sure hurts a lot and beat red. Follow-up ((b)(4); (b)(6) 2018): follow-up with patient. No significant information was received.
Patient Sequence No: 1, Text Type: N, H10
[103555923]
Wrong technique in drug usage process, overdose, application site pain, redness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00007 |
| MDR Report Key | 7366172 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date Added to Maude | 2018-03-23 |
| 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 DRIVE |
| 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 | 2018-03-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, LNC. |
| Manufacturer Address | 25 UPTON DRIVE WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |