SUNDASH RADIUS 252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for SUNDASH RADIUS 252 manufactured by Jk Products & Services.

Event Text Entries

[60027198] A 806 submitted to the (b)(6) district office of the fda. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10

[60027199] We received information that a wiring harness melted on a unit.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2311923-2016-00002
• MDR Report Key: 6090131
• Date Received: 2016-11-09
• Date of Report: 2016-11-09
• Date of Event: 2016-10-12
• Date Mfgr Received: 2016-10-12
• Device Manufacturer Date: 2003-01-09
• Date Added to Maude: 2016-11-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. KEVIN HART
• Manufacturer Street: 1 WALTER KRATZ DRIVE
• Manufacturer City: JONESBORO AR 72401
• Manufacturer Country: US
• Manufacturer Postal: 72401
• Manufacturer Phone: 8709351130
• Manufacturer G1: JK PRODUCTS & SERVICES
• Manufacturer Street: 1 WALTER KRATZ DRIVE
• Manufacturer City: JONESBORO AR 72401
• Manufacturer Country: US
• Manufacturer Postal Code: 72401
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: Z-2635-2014
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SUNDASH
• Generic Name: SUNTAN BED
• Product Code: LEJ
• Date Received: 2016-11-09
• Model Number: RADIUS 252
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: JK PRODUCTS & SERVICES
• Manufacturer Address: 1 WALTER KRATZ DRIVE JONESBORO AR 72401 US 72401

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-11-09