MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc..
[103951538]
Patient went in for her second treatment for actinic keratosis. Patient stated that the product was left on her face for 2 hours and then she went back to receive the blu-u treatment. When she went back for the light treatment, the medical staff was unable to get the light to turn on. They incubated her for an additional 30 minutes while they attempted to get the machine to function properly, however it never turned on so she was unable to receive the blu-u treatment. The patient is experiencing face is beet red and burning similar to a sunburn. Follow-up ((b)(4); 27-feb-18): no significant information was received.
Patient Sequence No: 1, Text Type: N, H10
[103951539]
Wrong technique in drug usage process, device failure, reaction nonspecific, red face, burning sensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00008 |
| MDR Report Key | 7378414 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-28 |
| 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 | 2018-03-28 |
| 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 | 2018-03-28 |