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 |