FLEX 3S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-19 for FLEX 3S manufactured by Inada Massage Chairs.

Event Text Entries

[21791665] I purchased the inada flex 3s massage chair directly from the manufacturer inada, and the chair was delivered on saturday (b)(6) 2015. After delivery, the chair was plugged into a high quality surge protector per manufacturer instructions, and the surge protector was plugged into a grounded outlet per manufacturer instructions. I used the chair several times between saturday (b)(6) 2015 and wednesday (b)(6) 2014, and i felt electrical current, tingling, and pain in my hands and feet which got progressively worse with each use. At first i thought this was an intentional part of the massage, but after contacting the manufacturer on (b)(6) i was informed that it is supposed to be heat on the hands and feet. It turned out that i was repeatedly electrocuted on my hands and feet by this defective product. As of today ((b)(6) 2015) my feet are still tingling and painful. Purchase date: (b)(6) 2015. I contacted the manufacturer for a refund. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5043219
• MDR Report Key: 4867587
• Date Received: 2015-06-19
• Date of Report: 2015-04-21
• Date of Event: 2015-04-11
• Date Added to Maude: 2015-06-26
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FLEX 3S
• Generic Name: INADA MASSAGE CHAIR MODEL FLEX 3S
• Product Code: ISA
• Date Received: 2015-06-19
• Model Number: FLEX 3
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INADA MASSAGE CHAIRS
• Manufacturer Address: 2125 32ND ST. BOULDER CO 80301 US 80301

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-06-19