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

Model Number FB-380HJ

Device Problem Smoking (1585)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 307783715
• Report Number: 3011108694-2022-00002
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 00031262082268
• UDI-Public: 00031262082268
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: FB-380HJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male