SUNDASH SR48

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-29 for SUNDASH SR48 manufactured by Jk Products & Services, Inc..

Event Text Entries

[15095854] Complainant closed the door of the tanning unit on her foot while entering the unit. She received 5 stitches on her heel.
Patient Sequence No: 1, Text Type: D, B5

[15461887] The production of this unit was stopped in 2001. This is the only known incident of this kind. We have provided salon owner labeling to place on unit to avoid future occurrences.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2311923-2013-00002
• MDR Report Key: 3173419
• Report Source: 06
• Date Received: 2013-04-29
• Date of Report: 2013-04-29
• Date of Event: 2013-04-19
• Date Mfgr Received: 2013-04-22
• Device Manufacturer Date: 1999-05-01
• Date Added to Maude: 2013-06-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Event Location: 0
• Manufacturer Contact: LATEEF KHAN
• Manufacturer Street: 1 WALTER KRATZ DR.
• Manufacturer City: JONESBORO AR 72401
• Manufacturer Country: US
• Manufacturer Postal: 72401
• Manufacturer Phone: 8702682700
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUNDASH
• Generic Name: RADIUS 48
• Product Code: LEJ
• Date Received: 2013-04-29
• Model Number: SR48
• Operator: OTHER
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JK PRODUCTS & SERVICES, INC.
• Manufacturer Address: 1 WALTER KRATZ DR. JONESBORO AR US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-04-29