FDA Adverse Event Other Summary report: N

SUNDASH

MDR report key: 3982912 · Received July 10, 2014

Report

Report Number
2311923-2014-00005
Event Type
Other
Date Received
July 10, 2014
Date of Event
May 6, 2013
Report Date
July 9, 2014
Manufacturer
JK PRODUCTS & SERVICES, INC.
Product Code
LEJ
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AR, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER TANNED FOR AN HOUR, WHICH IS FORTY MINUTES LONGER THAN WHAT THE LISTED EXPOSURE TIME ON THE EXPOSURE LABEL FOR THE TANNING BED.

Description of Event or Problem · 1

WIRING IN POWER HARNESS SHORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
405305 SUNDASH ENDURANCE LEJ JK PRODUCTS & SERVICES, INC. 424 SL

Patients

Seq Age Sex Outcome Treatment
1