BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 22169838 · Received June 9, 2025

    Report

    Report Number
    3014522447-2025-00005
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 9, 2025
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008010
    PMA / PMN Number
    K210920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MOBIUS MOBILITY MADE MULTIPLE REQUESTS FOR ACCESS TO THE DEVICE FOR INVESTIGATION, BUT IT WAS NOT MADE AVAILABLE. THE USER WAS INTERVIEWED BY THE MOBIUS MOBILITY SERVICE TEAM. THE USER DID NOT INDICATE HE HAD ANY ISSUES WITH THE IBOT. MOBIUS MOBILITY REVIEWED THE USER'S ORIGINAL DEVICE CONFIGURATION AND THE HISTORY OF SUPPORT CALLS AND PARTS REQUESTS FROM THE USER. THE USER HAD A FIXED CENTER MOUNT FOOT PLATFORM WITH CALFPADS AND RUBBER COATED ADJUSTABLE ANGLE FOOT PLATE (11.5 INCH X 10 INCH). THE DEVICE ALSO HAD LATERAL THIGH SUPPORTS THAT HAD BEEN ADJUSTED TO PROVIDE DISTAL SUPPORT AT HIS KNEES. THERE WERE NO LEG STRAPS ON THE ORDER AND THERE WERE NO CALLS FROM THE USER INDICATING THAT THEY WERE HAVING ISSUES KEEPING THEIR FEET ON THE FOOT PLATE. IN REVIEWING THE TRAINING RECORD WITH THE ASSISTIVE TECHNOLOGY PROFESSIONAL THAT PERFORMED THE TRAINING, THE USER HAD NO ISSUES KEEPING HIS FEET ON THE FOOT PLATE WHEN MANEUVERING IN STANDARD, 4-WHEEL, BALANCE, OR STAIR MODES. THE USER HAD, AFTER DELIVERY, REVERSED THE LATERAL THIGH SUPPORTS MAKING THEM MORE PROXIMALLY POSITIONED AND THIS ADJUSTMENT COULD RESULT IN THE LACK OF FOOT/LEG CONTROL WHEN USING THE DEVICE, CONTRIBUTING TO THE INCIDENT.

    Description of Event or Problem · 0

    USER WAS DRIVING IBOT® PMD ON THE SIDEWALK AND THEIR FOOT SLIPPED OFF THE FOOTPLATE RESULTING IN THE USER DRIVING OVER THEIR OWN ANKLE. THE EVENT RESULTED IN A FRACTURED ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265589 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention