MAUDE Adverse Event Report: UNKNOWN BEAUTYKO EVERTONE SAUNA BELT; CABLES, SURGE & POWER PROTECTION

Model Number BEAUTYKO EVERTONE SAUNA BELT

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385); Off-Label Use (1494); Failure to Auto Stop (2938)

Patient Problem Anxiety (2328)

Event Date 12/09/2016

Event Type  Other  

Event Description

I was using the product daily to heat a shoulder injury (laying it open upon my shoulder).The onto it, it began to heat.Either way, this product does not have a self-shut down when it gets too hot, and there is no way that it should begin to burn and melt.There was a warning to not "bend it", although i had no idea it would self-ignite.I've had to discard my mattress and sheets and comforter, and am experiencing some stress responses to waking up in the middle of the night with my bed on fire.I have learned to unplug everything.I had another heating pad for my back in the bed, plugged in, and that product turns off when getting too hot (even though i turn them both off before sleep).(b)(4).

• Brand Name: BEAUTYKO EVERTONE SAUNA BELT
• Type of Device: CABLES, SURGE & POWER PROTECTION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6263456
• MDR Text Key: 65279281
• Report Number: MW5067316
• Device Sequence Number: 1
• Product Code: NGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: BEAUTYKO EVERTONE SAUNA BELT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR