MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for UV / PHOTOTHERAPY YK-6000BT manufactured by Yonker Medical / Xuzhou Yongkang Electronic Scienc.
Report Number | 3013482554-2019-00002 |
MDR Report Key | 8890818 |
Date Received | 2019-08-13 |
Date of Report | 2019-05-17 |
Date of Event | 2019-05-17 |
Date Added to Maude | 2019-08-13 |
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 | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. XIAO WAN |
Manufacturer City | XUZHOU, JIANGSU 221000 |
Manufacturer Country | CH |
Manufacturer Postal | 221000 |
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 | 2019-08-13 |
Model Number | YK-6000BT |
Device Availability | * |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | YONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENC |
Manufacturer Address | XUZHOU 221000 CH 221000 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-08-13 |