MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-13 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR D2009 manufactured by Dusa Pharmaceuticals, Lnc..
[111003672]
Reporter stated that patient had a pdt treatment and does not remember driving himself home. Follow-up ((b)(6)2018; (b)(6) 2018): no significant information was received. Follow-up ((b)(6) 2018; (b)(6) 2018): reporter stated that patient had levulan pdt reaction. Upon receipt of this information, case became valid. Follow-up ((b)(6) 2018; (b)(6) 2018): no significant information was received. Follow-up ((b)(6) 2018; (b)(6) 2018): reporter stated the patient had severe sun damage, so he was incubated for 1 hour. The patient was barely able to stay under the blu-u for 30 seconds because he was in so much pain after being placed under it. After treatment the patient had gone home and mentioned to his wife that he doesn't remember how he had gotten home, which the reporter referred to as temporary transient aphasia. The reporter mentioned that the office received pictures of the patient's progress with treatment and that he experienced a normal reaction of scabbing. Follow-up ((b)(6) 2018; (b)(6) 2018): no significant information was received. Follow-up ((b)(6) 2018; (b)(6) 2018): no significant information was received. Follow-up ((b)(6) 2018; (b)(6) 2018): no adverse event related significant information was received.
Patient Sequence No: 1, Text Type: N, H10
[111003673]
Memory impairment. Reaction nonspecific. Wrong technique in drug usage process. Pain. Transient aphasia. Scabbing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00013 |
| MDR Report Key | 7596958 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-06-13 |
| 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 | 3 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR |
| Generic Name | BLU-U |
| Product Code | MVF |
| Date Received | 2018-06-13 |
| Catalog Number | D2009 |
| Lot Number | 003570 |
| 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 | 1. Hospitalization | 2018-06-13 |