MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc..
[112547738]
Reporter stated that patient had macular degeneration surgery 2 weeks prior to the blu-u light. During the treatment his goggles fell off and he was informed to just keep his eyes closed. The procedure was completed. Within two weeks he had pain and sought treatment for a detached retina. The reporter stated the patient is on the mend but has been through quite a painful ordeal and both specialists that he consulted felt that it was from the heat associated with the blu-u light treatment. Follow-up ((b)(4); 21-jun-2018): no significant information was received.
Patient Sequence No: 1, Text Type: N, H10
[112547739]
Pain, detached retina, radiation injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00014 |
| MDR Report Key | 7643715 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-09-07 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-06-27 |
| 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 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 | 2018-06-27 |
| Device Availability | * |
| Device Age | DA |
| 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 | 1. Other | 2018-06-27 |