UV / PHOTOTHERAPY YK-6000BT

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number3013482554-2019-00002
MDR Report Key8890818
Date Received2019-08-13
Date of Report2019-05-17
Date of Event2019-05-17
Date Added to Maude2019-08-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. XIAO WAN
Manufacturer CityXUZHOU, JIANGSU 221000
Manufacturer CountryCH
Manufacturer Postal221000
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUV / PHOTOTHERAPY
Generic NameLIGHT, ULTRAVIOLET, DERMATOLOGICAL
Product CodeFTC
Date Received2019-08-13
Model NumberYK-6000BT
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerYONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENC
Manufacturer AddressXUZHOU 221000 CH 221000


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.