MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc..
[101696514]
Patient reported the following: i'm (b)(6) and have been treated by my dermatologist for many years, with great success, with your 'blue light' treatment with levulan kerastick. In (b)(6) 2017 my regular dermatologist left her practice, where i had been treated for almost 10 years. While she was searching for a new practice, i asked my personal m. D. For a recommendation and started with a new dermatologist. I wasn't sure if or when i'd see my original dermatologist again and wanted to get help with some other skin issues. Since i had such good results with the blue light in the past, i asked about getting a treatment before years end. I had met all my deductibles and copay for the year (2017), so my insurance ((b)(6)) would cover all the costs. But when i went in for the treatment on my appointed (b)(6) date, it soon became clear the doctor and assistants had no idea how to administer the levulan with kerastick protocol. Half the bulbs in the blue light machine were burned out and it took three different assistants to try and figure out how to even turn it on. The doctor had no idea how to apply the kerastick and didn't even bend it to activate the mixture of the medicines in the kerastick. After just 7 minutes under the half lit [? ]blue light', they said "all done! " i explained i had done the treatment at least 6 times before with my prior dermatologist and the time under [? ]the light' was supposed to be much longer, closer to 20 minutes i thought. And that was with all the bulbs working. But they allowed me just 5 more minutes, 12 total, but again with only half the bulbs working. It's hard to tell a new doctor doing a procedure on me for the first time that i don't think anyone knows what they're doing! But there was certainly no reason to schedule a follow up with this doctor or practice. Needless to say, it was as though nothing happened at all, (and actually it hadn't! ). I certainly have no desire to return to this doctor or practice, but also don't want a big fight, lawsuit, file a complaint to the board of dermatologists, or advise my insurance. I didn't have a hidden camera or audio recorder as i had no reason to anticipate their ineptitude. Quite honestly, filing any kind of legal complaints is simply too much stress. I wouldn't even be writing you now but want you to know that the success or failure of this product and process rests in great part to the doctor and staff knowing how it works, having a working blue light machine (with all the bulbs working! ) and following the times and processes detailed in the protocol. But there's good news! My original dermatologist has recently joined a very well respected and long established practice and they know and frequently administer the levulan kerastick product. I wish i'd found her before i went to the other doctor and practice who were not familiar. But as it was (b)(6), i was eager to get the treatment before years end. And of course i had no way to know the replacement dermatologist was not familiar with how levulan kerastick is supposed to be administered. And now it's a new year, and i will have to pay hundreds of dollars to have my doctor in her new practice administer another treatment. Last week i had my first exam with my original dermatologist in her new practice and she even noted she saw no indication i had even had a recent blue light treatment even though it happened just two weeks prior. As i said, clearly it was because nothing was done! I am reluctant to give you any names as i don't want to be sued for slander. But i think you owe it to your customers to have regular blue light machine inspections and protocol recertification, so other patients don't have the same bad experience i had. I can't afford all the costs, so i'll have to wait for my next blue light treatment. But if you need a test patient i'd volunteer my scalp to demonstrate what a great product it is. But of course you already know this! Thanks for allowing me to express my gratitude for my excellent prior results, but also my extreme disappointment that my most recent experience at the hands of an unfamiliar doctor and staff too interested in profits than taking proper care of their patients was such a total failure. Follow-up (23-jan-2018, tr# (b)(4)): follow-up was performed to obtain further information.
Patient Sequence No: 1, Text Type: N, H10
[101696515]
Nothing happened at all, no indication had treatment time under 'the light' was supposed to be much longer half the bulbs in the blue light burned out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226354-2018-00002 |
| MDR Report Key | 7308135 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-03-01 |
| 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 WILMINGTON |
| Manufacturer City | 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 | 2018-03-01 |
| 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 | 2018-03-01 |