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U.S. Department of Health and Human Services

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

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NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD HOMEDICS BUBBLE BLISS ELITE FOOTBATH; FOOT BATH Back to Search Results
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.
 
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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 Key15812544
MDR Text Key303792271
Report Number3011108694-2022-00001
Device Sequence Number1
Product Code ISA
UDI-Device Identifier00031262082268
UDI-Public00031262082268
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberFB-380HJ
Device Catalogue NumberFB-380HJ
Device Lot Number1421
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/13/2022
Initial Date FDA Received11/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
SUPRAPUBIC UROLOGICAL CATHETER
Patient Outcome(s) Disability; Death;
Patient Age60 YR
Patient SexMale
Patient RaceBlack Or African American
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