BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEDICS SHIATSU+ 4.0 FOOT MASSAGER WITH HEAT

    MDR report key: 23717825 · Received December 4, 2025

    Report

    Report Number
    MW5179907
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    September 14, 2025
    Report Date
    November 28, 2025
    Manufacturer
    HOMEDICS GROUP CANADA
    Product Code
    ISA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY MOTHER, (B)(6), USED THE HOMEDICS SHIATSU+ 4.0 FOOT MASSAGER WITH HEAT AS DIRECTED. SHE HAS DIABETIC NEUROPATHY IN HER FEET, WHICH LIMITS HER ABILITY TO FEEL HEAT OR PAIN. WHILE USING THE DEVICE, THE HEATING ELEMENT CAUSED A SEVERE BURN ON HER FOOT. BECAUSE OF HER NEUROPATHY, SHE DID NOT REALIZE SHE WAS BEING BURNED. THE BURN WORSENED DESPITE ATTEMPTS TO TREAT IT AT HOME. IT BECAME INFECTED AND PROGRESSED TO A SERIOUS MEDICAL CONDITION, EVENTUALLY RESULTING IN HOSPITALIZATION AND THE AMPUTATION OF ONE OF HER TOES. SHE HAD MULTIPLE MEDICAL VISITS, INCLUDING TWO HOSPITAL STAYS. DOCTORS CONFIRMED THE INFECTION STARTED AT THE SITE OF THE BURN CAUSED BY THE MASSAGER. SHE WAS ADMITTED TO THE HOSPITAL (B)(6) FOR BACTERIA IN HER BLOOD. THEY FOUND OUT THE BACTERIA WAS COMING FROM HER TOE WHICH WAS BURNED FROM THE FOOT MASSAGER. THE TOE WAS INFECTED AND HAD TO BE AMPUTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849289 HOMEDICS SHIATSU+ 4.0 FOOT MASSAGER WITH HEAT MASSAGER, THERAPEUTIC, ELECTRIC ISA HOMEDICS GROUP CANADA FMS-347HJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other| S| H AMLODIPINE| ATORVASTATIN | DIABETIC HEALTH PACK VITAMINS| FARXIGA| FEROSUL| GABAPENTIN | HUMALOG| LANTUS INSULIN