TANNING BED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for TANNING BED manufactured by Unk.

Event Text Entries

[89694730] I used the tanning bed at (b)(6) on (b)(6) 2017, and believe it is malfunctioning. I have used tanning beds for several years and have not had a burning incident yet. I used the bed for a typical amount of time for me, which was 12 minutes. I had 1st degree burns covering my entire body and 2nd degree burns on my upper back. I also was not offered eye protection to use during the tanning period. When i asked for a full 20 minutes (which i have used successfully before), the manager was very hesitant to offer that time. He said i would probably burn if i did that. I also heard a staff member behind him whisper to another person "oh that poor girl! " this leads me to believe they are aware the machine is not tanning correctly and can burn users quickly. I would like to have the machines investigated to find out if they are no longer working correctly in order to protect any future users.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072818
• MDR Report Key: 6958155
• Date Received: 2017-10-18
• Date of Report: 2017-10-16
• Date of Event: 2017-10-13
• Date Added to Maude: 2017-10-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TANNING BED
• Generic Name: TANNING BED
• Product Code: REF
• Date Received: 2017-10-18
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-10-18