MAUDE Adverse Event Report: UV PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Burn, Thermal (2530)

Event Date 01/22/2021

Event Type  Injury  

Event Description

Burned my palm and finger; 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; (b)(6).Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 11243801
• MDR Text Key: 229880882
• Report Number: MW5099073
• Device Sequence Number: 1
• Product Code: FTC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability