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

Model Number FB-380HJ

Device Problems Off-Label Use (1494); Therapeutic or Diagnostic Output Failure (3023); Excessive Heating (4030)

Patient Problems Device Overstimulation of Tissue (1991); Post Operative Wound Infection (2446); Partial thickness (Second Degree) Burn (2694)

Event Date 06/13/2021

Event Type  Death  

Manufacturer Narrative

Cause of death as stated on the death certificate is as follows: i.Immediate cause: hypertensive cardiovascular disease; ii.Subsequent condition(s): epilepsy; iii.Underlying cause: diabetes; iv.Significant conditions contributing to death: bronchitis.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.".

Event Description

On or about (b)(6) 2021, the patient's personal care attendant prepared a bubble bliss elite footbath bathing machine that she had purchased.She filled the basin with water, turned on the machine, and placed the patient's feet in the basin to soak.The bubble bliss elite footbath is designed to provide a "heat boost" that heats the water to a therapeutic temperature.Unfortunately, however, while the patient's feet remained soaking in the basin, the machine allegedly heated the basin water rapidly and improperly to a hot temperature causing burns to the patient's feet.The patient suffers from diabetic neuropathy and was unable to discern the rising water temperature while soaking in the footbath machine.Summary per the ems record: ambulance "dispatched to location to a 59 y/o male chief complaint of burns to his feet.Upon arrival, ems is met downstairs and escorted to upstairs apartment.Pt is laying semi-fowler's in bed in back room, awake and alert.Home health care nurse states she got a new foot bath and was getting ready to clean pt's feet, but did not realize the water temperature before submerging pt's feet into bath.Upon ems arrival, pt has partial thickness burns to both feet with some bleeding, skin sloughing and weeping.Both skin and toenails are removed from foot.Pt has hx of cerebral palsy, previous cva, and diabetes.Pt states he was unable to feel his feet prior to this incident due to the diabetes and currently cannot feel his feet and is in no pain.Pt denies any chest pain, shortness of breath, dizziness, n/v, or any pain.Pt is awake and alert, gcs 15.Airway patent with no increased respiratory effort or accessory muscle usage noted.Eyes perrl.Trachea midline.Negative jvd.Abdomen soft and non-distended.Pt has suprapubic catheter in place.Pelvis stable.Cms intact to upper extremities.Pt is able to move lower extremities but unable to feel feet.Pt has partial thickness burns bilaterally to both feet with skin sloughing and weeping.Toenails have also sloughed off.Bsa about 5-10%.Initial vs, 4 lead ekg, cbg obtained.Dry, sterile dressings applied to both feet as documented above.Ems has removal delay as pt has to be carried from bed to stretcher.Pt is secured to stretcher with all straps and rails up and moved to downstairs level of apartment via elevator.Pt loaded into truck without incident.Transport initiated to (b)(6) emergency dept with burn activation.Pt's mental status, vs, and condition monitored en route with no change.Pt remains awake and alert and reports no pain.Upon arrival, pt is transferred to bed".After a prolonged course of medical care and attention, the patient's burns did not improve and his doctors concluded the only treatment option was a double amputation of his feet.The patient remained hospitalized and was eventually transferred for a course of rehabilitative care.The patient passed away on (b)(6) 2022.It was alleged that the death was caused by septis from the surgeries related to the amputation.

• 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: 15812544
• MDR Text Key: 303792271
• Report Number: 3011108694-2022-00001
• 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: 11/16/2022

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
• Device Operator: Other
• Device Model Number: FB-380HJ
• Device Catalogue Number: FB-380HJ
• Device Lot Number: 1421
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SUPRAPUBIC UROLOGICAL CATHETER
• Patient Outcome(s): Disability; Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: Black Or African American