BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 22080598 · Received May 23, 2025

    Report

    Report Number
    3014522447-2025-00004
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 23, 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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MOBIUS MOBILITY MADE MULTIPLE REQUESTS FOR ACCESS TO THE DEVICE FOR INVESTIGATION, BUT IT WAS NOT AVAILABLE. THE USER DID NOT WANT TO HAVE THE LOG DATA PULLED BY THE MOBIUS MOBILITY SERVICE TEAM. VETERANS AFFAIRS DID NOT SHARE THE CAUSE OF THE ACCIDENT OR PROVIDE ANY ADDITIONAL INFORMATION DURING THE INVESTIGATION. AT THIS TIME THERE IS NO INFORMATION TO INDICATE THAT THE IBOT PMD® CAUSED OR CONTRIBUTED TO THE ACCIDENT AS THE DRIVER OF THE F150 IS BELIEVED TO BE AT FAULT IN THE ACCIDENT.

    Description of Event or Problem · 0

    VETERANS AFFAIRS NOTIFIED MOBIUS MOBILITY ON (B)(6) 2025 THE USER WAS IN HOSPITAL BECAUSE OF A "CAR ACCIDENT" AND THERE WAS NO MENTIONED INVOLVEMENT OF THE IBOT® PMD. ON (B)(6) 2025 MOBIUS WAS THEN NOTIFIED BY THE CLINICIAN, THAT THE USER WAS IN HIS WHEELCHAIR AT THE TIME OF THE ACCIDENT. THE CLINICIAN INDICATED THAT USER WAS HIT BY A FORD F150 AND DID NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE CAUSE OF THE ACCIDENT. THE CLINICIAN DIDN'T INDICATE ANY ISSUES WITH THE IBOT® PMD AT THE TIME OF THE EVENT AND WAS LOOKING TO QUOTE A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220147 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Hospitalization