MAUDE Adverse Event Report: ULTIMATE PHYSICAL THERAPY MASSAGER WITH DIGITAL LCD DISPLAY

Model Number 390732448507

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Type  Other  

Event Description

I bought an ultimate physical therapy massager item id 390732448507 from (b)(6).It was a gift for my son for christmas to help with a stiff neck.He had the pads stuck down on his trapezoid muscles on both sides of his neck and after five minutes, one of the pads burned his skin.It left a burn in the shape of the stimulator pad.He said he heard a sound like it was shorting out then it started hurting before he was able to remove it.I contacted (b)(6) and their response was: "please contact your doctor." they had nothing to say about the unit, whether it could have been just one defective unit or if they had been having the same issue with other customers.Their response was bothersome, showing little or no concern about the product.Even more bothersome is the fact that they're selling something that is potentially dangerous.Injury, no first aid or medical attention received.Manufacturer: i don't know.It's from (b)(4).Purchase date: (b)(6) 2014.They have a 14 day return policy.I just found out about the incident.Document number: (b)(4).

• Brand Name: ULTIMATE PHYSICAL THERAPY MASSAGER WITH DIGITAL LCD DISPLAY
• Type of Device: ULTIMATE PHYSICAL THERAPY MASSAGER
• MDR Report Key: 4491673
• MDR Text Key: 17224159
• Report Number: MW5040623
• 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: Patient Family Member or Friend
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

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: 390732448507
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2015
• Patient Sequence Number: 1