EURGOLINE SUN ANGEL 1400 DUO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for EURGOLINE SUN ANGEL 1400 DUO manufactured by Jk Products & Services, Inc..

Event Text Entries

[177133756] I wanted to make you aware of a serious situation at a tanning salon i visited this evening: (b)(6). Most recent franchise owner i could locate is listed as (b)(6). On (b)(6) 2020 19:05 - 19:25 bed 12 sun angel electronic control panel non responsive, unable to control air, temperature or timing on tanning bed. Notified front desk clerk, blond, small frame, slim, roughly 18-22 y/o, of the issue listed above as well as my concerns. She informed me nothing she can do, many clients who came in earlier complained, she will inform mgr tomorrow. She instructed young brunette girl to go clean the bed. I explained that she is in violation of usfda of cfr title 21 chapter 1 sub-part b, that it is her legal responsible to shut down machine and not permit further clients to use. She said no, she will speak with her mgr tomorrow. I was forthright and informed both young women that i would be contacting both the usfda and the (b)(6) dept of health, and if she was not going to shut down the machine for the evening, that the wisest step would be to contact her leadership now and not wait. She was unconcerned. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092598
• MDR Report Key: 9641873
• Date Received: 2020-01-28
• Date of Report: 2020-01-25
• Date of Event: 2020-01-14
• Date Added to Maude: 2020-01-29
• 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
• Reporter Occupation: PATIENT
• 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: 3

Device Details

• Brand Name: EURGOLINE SUN ANGEL 1400 DUO
• Generic Name: BOOTH, SUN TAN
• Product Code: LEJ
• Date Received: 2020-01-28
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JK PRODUCTS & SERVICES, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-28