MAUDE Adverse Event Report: NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD HOMEDICS BUBBLE BLISS ELITE FOOTBATH; FOOT BATH

Model Number	FB-380HJ
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported he sometimes will doze off while using the spa because it's so relaxing.On this night, he was close to dozing off, but noticed a funny smell, followed by smoke.He saw the smokey bubbles coming out of the water and noticed the water was burning his feet.He pulled his feet out, smoke was filling the room.He unplugged the device and ran it outside.When the smoke cleared, he found a burn in his floor.He looked at the foot spa and it was clearly burned.Photographs of the footbath were provided.

• Brand Name: HOMEDICS BUBBLE BLISS ELITE FOOTBATH
• Common Device Name: FOOT BATH
• Manufacturer (Section D): NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD; macaotou,mazhu,yuyao; ningbo, zhejiang 31545 0; CH 315450
• Manufacturer (Section G): NINGBO LONGFU ELECTRICAL APPLIANCES & TOOL CO LTD; macaotou,mazhu,yuyao; ningbo, zhejiang 31545 0; CH 315450
• Manufacturer Contact: fanny zhao ; 19838 moon shadow circle; walnut, CA 91789 ; 9095100201
• MDR Report Key: 15891332
• Report Number: 3011108694-2022-00002
• Device Sequence Number: 5218628
• Product Code: ISA
• UDI-Device Identifier: 00031262082268
• UDI-Public: 00031262082268
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FB-380HJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male