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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/13/2021
Type of Reportable Event	Death
Event or Problem Description
On august 17, 2022 homedics was severed with a lawsuit that alleged the following: on or about (b)(6) 2021, ms.(b)(6) (personal care attendant) arrived at mr.(b)(6) home in (b)(6), to provide bathing and other custodial services.Ms.(b)(6) brought a bubble bliss elite footbath bathing machine, filled the basin with water, turned on the machine, and placed mr.(b)(6) feet in the basin to soak.The bubble bliss elite footbath is supposed to provide a "heat boost" to heat the water to a therapeutic temperature.Unfortunately, however, while mr.(b)(6) feet remained soaking in the basin, the machine rapidly and improperly heated the basin water to a hot temperature causing mr.(b)(6) feet to burn.Mr.(b)(6) suffers from diabetic neuropathy, and he was unable to discern the rising water temperature while soaking in the machine.Later that evening, mr.(b)(6) began to experience significant problems secondary to burns to both feet.Mr.(b)(6) was taken by ambulance to (b)(6) medical center for emergent medical care.After a prolonged course of medical care and attention, mr.(b)(6) burns did not improve, and his doctors concluded that the only treatment option was a double amputation of mr.(b)(6) feet.After undergoing the amputation of both feet, mr.(b)(6) remained hospitalized and was eventually transferred for a course of rehabilitative care.On august 22, 2022, homedics was notified through lawyers that mr.(b)(6) had passed away on (b)(6) 2022.It was alleged that the death was caused by septis from the surgeries related to his feet.
Additional Manufacturer Narrative
This product should not have been used on anyone with diabetic neuropathy per the following warnings and cautions in the ifu: warning: this product should never be used by any individual suffering from any physical ailment that would limit the user's capacity to operate the controls, or who has sensory deficiencies.Caution: not recommended for use by diabetics.This product was also used by a personal care attendant as part of her professional bathing and other custodial services, which contradicts the following caution statement: "this product is intended for household use only.".

• 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
• MDR Report Key: 15429348
• Report Number: 1832894-2022-00001
• Device Sequence Number: 4729060
• Product Code: ISA
• UDI-Device Identifier: 00031262082268
• UDI-Public: 00031262082268
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022
• Report Date (Section F): 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: FB-380HJ
• Device Catalogue Number: FB-380HJ
• Device Lot Number: 1421
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2022
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Disability
• Patient Age: 60 YR
• Patient Sex: Male