MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for YONKER UV PHOTOTHERAPY LAMP manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd.
[136885010]
I am a patient has psoriasis on arm. I bought a uvb lamp on (b)(6), the link is (b)(6). I used, according to their manual, the manual said it should be used under physician? S guide, but when i bought it, it hadn? T been noticed. I used it at home by myself , after 2 times irritation my skin got deep red and hurt like a burn. I complained to (b)(6) and the seller, they said this is a prescription medical device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084065 |
| MDR Report Key | 8339485 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-02-01 |
| Date Added to Maude | 2019-02-14 |
| 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 |
| 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 | YONKER UV PHOTOTHERAPY LAMP |
| Generic Name | LIGHT, ULTRAVIOLET, DERMATOLOGIAL |
| Product Code | FTC |
| Date Received | 2019-02-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-13 |