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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGEL KISS LLC UV PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL
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ANGEL KISS LLC UV PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL Back to Search Results
Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Event Date 01/22/2021
Event Type  Injury  
Event Description
Burned my skin; my husband bought me this lamp because i had eczema dyshidrotic on my palm and around my fingers.This lamp didn't help at all.I was still itching, burning and skin was breaking out nonstop.I only used it for 3 days and gave up because i felt like it wasn't speeding up the process or helping me heal.The link is here (b)(6).Its 510k number is k132643 which clearly shows that this is a prescription (rx) medical device.(b)(6) will be punished if (b)(6) don't take this case serious to remove it.Fda safety report id# (b)(4).
 
Event Description
Additional info received on 02/04/2021 from reporter for mw5099156.The reporter has added patient information, reporter address, and the operator of the device.Fda safety report id# (b)(4).
 
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Brand Name
UV PHOTOTHERAPY
Type of Device
LIGHT, ULTRAVIOLET, DERMATOLOGICAL
Manufacturer (Section D)
ANGEL KISS LLC
MDR Report Key11272394
MDR Text Key230328253
Report NumberMW5099156
Device Sequence Number1
Product Code FTC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
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; Disability;
Patient Age19 YR
Patient Weight70
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