BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 23524612 · Received November 11, 2025

    Report

    Report Number
    3014522447-2025-00009
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008010
    PMA / PMN Number
    K210920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MOBIUS MOBILITY ASSISTIVE TECHNOLOGY PROFESSIONAL (ATP) MET WITH THE USER ON (B)(6) 2025 AND HAD ACCESS TO THE DEVICE FOR INVESTIGATION. THE ATP REVIEWED WHAT HAPPENED WHEN HIS ANKLES WERE INJURED AND WHAT ADDITIONAL COULD BE DONE TO HELP PREVENT IT IN THE FUTURE. THIS IS THE USERS 2ND EVENT OF RUNNING OVER THEIR FEET (SEE REPORT NUMBER: 3014522447-2025-00005). THE USER WAS INTERVIEWED BY THE MOBIUS MOBILITY SERVICE TEAM AND INDICATED THAT HE WAS NOT USING THE POSITIONING STRAP AT THE TIME OF THIS EVENT. THE USER DID NOT INDICATE HE HAD ANY ISSUES WITH THE IBOT NOR DID THE ATP FIND ANY ISSUES ON (B)(6) 2025. MOBIUS MOBILITY REVIEWED THE USER'S ORIGINAL DEVICE CONFIGURATION AND THE HISTORY OF SUPPORT CALL AND PARTS REQUESTS FROM THE USER. THE USER ADJUSTED THEIR THIGH GUIDES, SO THEY STUCK OUT THE FRONT, AND STARTED USING A POSITIONING STRAP AROUND THEIR LEGS ((B)(6) 2025).

    Description of Event or Problem · 0

    AN IBOT USER CALLED TO REPORT THAT HE HAD AN INCIDENT AT APPROXIMATELY 11AM ON (B)(6) WHEN HE RAN OVER HIS RIGHT FOOT, RESULTING IN THE BREAKING OF 2 BONES (BIMALLEOLAR ANKLE FRACTURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503310 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention