BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMEDICS BUBBLE BLISS ELITE FOOTBATH

    MDR report key: 15429348 · Received September 15, 2022

    Report

    Report Number
    1832894-2022-00001
    Event Type
    Death
    Date Received
    September 15, 2022
    Date of Event
    June 13, 2021
    Report Date
    August 31, 2022
    Manufacturer
    NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD
    Product Code
    ISA
    UDI-DI
    00031262082268
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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."

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475191 HOMEDICS BUBBLE BLISS ELITE FOOTBATH FOOT BATH ISA NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD FB-380HJ 1421 00031262082268

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death| S