MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-14 for YONKER UVB PHOTOTHERAPY INSTRUMENT. manufactured by .
[77741414]
I brought the device "yonker uvb-narrowband-lamp-311nm-phototherapy" on (b)(6), and found it has no instruction on how to use it. Then i used it for 3 minutes on my arm and my arm got burned. I checked the device and it was made-in-(b)(4) and i can't find any information on the fda website. I suspect it is a non-fda approved product that can cause serious burn to the body. Frequency: twice a day. How was it taken or used: topical. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after the product reduced the dose or stopped taking or using the product: yes. Did the product return if the person started taking or using the product again: yes. Why was the person using the product: i have vitiligo on my left arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070412 |
| MDR Report Key | 6642914 |
| Date Received | 2017-06-14 |
| Date of Event | 2017-06-10 |
| Date Added to Maude | 2017-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | YONKER UVB PHOTOTHERAPY INSTRUMENT. |
| Generic Name | XUZHOU YONGKANG ELECTRONIC SCIENCE |
| Product Code | FTC |
| Date Received | 2017-06-14 |
| Device Expiration Date | 2017-06-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Deathisabilit | 2017-06-14 |