MAUDE Adverse Event Report: TANNING BED; BOOTH, SUN TAN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Radiation Burn (1755); Burn(s) (1757); Swelling (2091)

Event Date 03/17/2018

Event Type  Injury  

Event Description

Will have the exact date when i go in store the next two days to talk to them in person.(b)(4) only cares about money and no one's health.They highly encourage employees to upsell clients as fast as they can to stronger beds.I never get much sun anymore but as a child i never burnt and explained that to them.I asked them as much info as i could and their employees had very little answers.Within the second week of my membership, they upsold me for the strongest bed and put me underneath for 5-7 mins.I asked the girl working several times "i don't want to burn; will i burn?" to which i was told no.I burnt so bad, i had blister all over my skin.I hid it from my parents who i live with and told me it was a horrible idea, so no pictures were taken.But i do have over 7 friends who had seen me during that time willing to speak on my behalf, and it's truly horrible.I have not been here in 5 months and have tried calling repeated times, and have even tried to send in a request to cancel my membership and they still have not and continuously change my card with no permission granted, and i have called and left messages multiple times.They still have yet to answer or return my call.I have a friend who wants to stay anonymous (if followed up with by medwatch i can provide contact info) in fear of getting her fired, who works at (b)(4) that says their owner and mgmt pushes them to upsell tanning beds and tanning lotion, even if that puts the guest at risk and does not care about their skin or their money the minute they give it to the salon.They even threaten people who have terrible experiences and have signed their 6 month contract to pass them off to collections even if they haven't been in within the first two weeks.None of their employees have tanning bed operator certifications and all of them carry very little knowledge.Cosmetologists need licenses because carelessness can lead to injury.Tanning bed operators need certification as well as limited times and basic to put new people who have never tanned to avoid extreme injury from greedy business.We're dealing with skin cancer here.I have never burned and took such good skin up until my fateful experience in (b)(6).Now, i have to worry about getting skin cancer and constantly watch my bank account be changed for something i haven't used in 5 months which is another issue being reported to a different sector.I always get directed to the guest of head services who never returns my calls or emails within the past 5 months.This company needs to either be highly regulated or shut down for negligence of health.(b)(4).

• Brand Name: TANNING BED
• Type of Device: BOOTH, SUN TAN
• MDR Report Key: 7902008
• MDR Text Key: 121806033
• Report Number: MW5080072
• Device Sequence Number: 1
• Product Code: LEJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 61