MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for UV / PHOTOTHERAPY YK8000BT manufactured by Yonker Medical / Xuzhou Yongkang Electronic Science Technology Co., Ltd.
[145934444]
I just received a uvb wand and the instructions are in chinese/english. I do not know where to start. I found out that the unit requires a prescription from my dr. No one said that, my friend says do not use it. There is an instruction that says if i get burned, increase treatment time and i am not sure about that. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086811 |
| MDR Report Key | 8631999 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-17 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UV / PHOTOTHERAPY |
| Generic Name | LIGHT, ULTRAVIOLET, DERMATOLOGICAL |
| Product Code | FTC |
| Date Received | 2019-05-21 |
| Model Number | YK8000BT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | YONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD |
| Brand Name | UV / PHOTOTHERAPY |
| Generic Name | LIGHT, ULTRAVIOLET, DERMATOLOGICAL |
| Product Code | FTC |
| Date Received | 2019-05-21 |
| Model Number | YK8000BT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YONKER MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |