FDA Adverse Event Malfunction Summary report: N

SUNDASH

MDR report key: 2563053 · Received April 16, 2012

Report

Report Number
2311923-2012-00014
Event Type
Malfunction
Date Received
April 16, 2012
Date of Event
December 7, 2006
Report Date
April 16, 2012
Manufacturer
JK PRODUCTS & SERVICE, INC.
Product Code
LEJ
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

CLAIMANT ALLEGES CORD FAILURE ON TANNING BOOTH CAUSED FIRE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUNDASH RADIUS 252 LEJ JK PRODUCTS & SERVICE, INC. 252 NA

Patients

Seq Age Sex Outcome Treatment
1 Other