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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD PSORIASIS LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL
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XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD PSORIASIS LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL Back to Search Results
Model Number KN-4003BL
Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Patient Problem Itching Sensation (1943)
Event Date 01/10/2021
Event Type  Injury  
Event Description
Ruined my skin; bought a psoriasis lamp from (b)(6).Do not use! i would give this zero stars if i could, because this made my plaque psoriasis itch like there was no tomorrow! it took 3 weeks after i stopped using this product before my plaque psoriasis stopped itching.I would wake up in the middle of the night and my legs would be itching so bad that i couldn't go back to sleep, and my legs only started itching after using this product! this crap is expensive, so use at your own risk.Us food and drug administration restricts this psoriasis lamp to sell without the order of a physician.Therapy start date: (b)(6) 2021; stopped date: (b)(6) 2021.Fda safety report id # (b)(4).
 
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Brand Name
PSORIASIS LAMP
Type of Device
LIGHT, ULTRAVIOLET, DERMATOLOGICAL
Manufacturer (Section D)
XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO LTD
MDR Report Key11285561
MDR Text Key230731916
Report NumberMW5099241
Device Sequence Number1
Product Code FTC
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberKN-4003BL
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age45 YR
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