MAUDE Adverse Event Report: INADA MASSAGE CHAIRS FLEX 3S; INADA MASSAGE CHAIR MODEL FLEX 3S

Model Number FLEX 3

Device Problem Electro-Static Discharge (2149)

Patient Problems Electrocution (1827); Pain (1994); Tingling (2171); Electric Shock (2554)

Event Date 04/11/2015

Event Type  Other  

Event Description

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).

• Brand Name: FLEX 3S
• Type of Device: INADA MASSAGE CHAIR MODEL FLEX 3S
• Manufacturer (Section D): INADA MASSAGE CHAIRS; 2125 32nd st.; boulder CO 80301
• MDR Report Key: 4867587
• MDR Text Key: 21791665
• Report Number: MW5043219
• Device Sequence Number: 1
• Product Code: ISA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: FLEX 3
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2015
• Patient Sequence Number: 1
• Patient Age: 45 YR