MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2015-10-08 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR 4170-1D 4170 manufactured by Dusa Pharmaceuticals, Inc..
[28072191]
On (b)(6), 2015 information was received from a (b)(6) male patient who received treatment for actinic keratoses on (b)(6), 2013 with levulan kerastick and blu-u blue light photodynamic therapy illuminator consisting of application of the levulan kerastick to the entire face, followed by exposure to blu-u light. The patient reported wearing goggles during light exposure and denies any levulan dripped into his eyes. He also denies any pain, stinging or discomfort in the eyes. On (b)(6), 2013, the patient reported he awoke with a slight amount of vision loss in his left eye. He went to his ophthalmologist who believes the vision loss may have been caused by a slight stroke involving the optic nerves. On (b)(6), 2013, the patient reported being completely blind in the left eye. He was examined by a second ophthalmologist on (b)(6), 2013, and intraocular fluid from the left eye was taken and tested positive for shingles virus strain, which may have been in its dormant state. The patient reported the ophthalmologist felt that the shock of the pdt treatment probably agitated the dormant singles virus, making it attack the optic nerve causing blindness. As of (b)(6), 2015 the patient reported the event f total blindness in the left eye is on-going. According the company's chief medical officer, the reported event of unilateral blindness occurring 11 days post pdt in the absence of pain, swelling, inflammation or spillage of levulan despite the finding of herpes virus in intraocular fluid, the course of this specific case is far more typical of optic neuritis than of a reactivated herpes virus infection.
Patient Sequence No: 1, Text Type: D, B5
[106890927]
Additional information received: on (b)(6) 2013 a male patient received his second treatment for actinic keratoses (aks) with levulan kerastick and blu-u blue light photodynamic therapy illuminator consisting of a skin preparation of two (2) passes with acetone wipes to degrease the skin, followed by application of levulan to the entire face, incubation for 1 hour. Patient was provided with, and put on appropriate goggles prior to placement under the blu-u light, and was exposed to light source for 16 minutes 40 seconds. Of note, the patient was treated prophylactically with acyclovir 800mg one day prior to and the day of pdt treatment. The treatment was well tolerated. Post procedure titanium and zinc sunscreen was applied to the patients face and instructions for sun avoidance were given, as well as information for patient to call should he experience excessive pain, swelling, cold sores etc. The ophthalmologist reported: rr experienced left acute retinal necrosis (arn) following pdt treatment, "he does not know if the treatment was the cause of the zoster in the patients eye, many patients get ocular zoster, and the cause is not known, but the virus (zoster) is the cause of the blindness". No further information is expected. According to the company's chief medical officer, the new information received does not change the medical assessment of the event which was unlikely to be related to levulan pdt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2015-00001 |
| MDR Report Key | 5141754 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-08 |
| Date of Event | 2013-09-07 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-10-09 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JOANNE LAVALLE |
| Manufacturer Street | 25 UPTON DR. |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal | 01887 |
| Manufacturer Phone | 9789092281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR |
| Generic Name | BLU-U |
| Product Code | MVF |
| Date Received | 2015-10-08 |
| Model Number | 4170-1D |
| Catalog Number | 4170 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUSA PHARMACEUTICALS, INC. |
| Manufacturer Address | 25 UPTON DR. WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2015-10-08 |