BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F3

    MDR report key: 25318964 · Received May 28, 2026

    Report

    Report Number
    1221084-2026-00007
    Event Type
    Death
    Date Received
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818676433
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS SERVED WITH A LAWSUIT ON BEHALF OF THE DECEASED END-USER'S ESTATE. THE LAWSUIT ALLEGES THAT THE END-USER WAS DESCENDING A PORTABLE RAMP OUTSIDE HIS SISTER'S RESIDENCE WHEN THE DEVICE TIPPED OVER FORWARD AND CRUSHED HIM. THE END-USER WAS TAKEN TO THE LOCAL HOSPITAL WHERE HE SUCCUMBED TO UNDISCLOSED INJURIES AND DIED THE FOLLOWING DAY. THE LEGAL COMPLAINT ALLEGES THAT THE FAULT FOR THE EVENT WAS DUE TO THE DEVICE NOT HAVING "ANTI TIPPERS/SUPPORT WHEELS" INSTALLED ON THE DEVICE AT DISTRIBUTION FROM MANUFACTURING OR HAVING BEEN REMOVED PRIOR TO DISTRIBUTION TO THE END-USER AND FAILURE TO WARN OF POSSIBLE HARM IF NOT INSTALLED. THERE ARE NO OTHER CLAIMS OR ALLEGATIONS OF ANY OTHER PRODUCT MALFUNCTION HAVING OCCURRED. A REVIEW OF DEVICE HISTORY WAS CONDUCTED, AND IT WAS NOTED THAT THE DEVICE WAS CONFIGURED AND SHIPPED WITH THE FRONT SUPPORT WHEELS INSTALLED. REVIEW OF DEVICE PHOTOS AT SHIPPING CONFIRMS THE DEVICE WAS SHIPPED WITH THE FRONT SUPPORT WHEELS INSTALLED. IT REMAINS UNCLEAR WHEN THE FRONT SUPPORT WHEELS WERE REMOVED AS CLAIMED OR BY WHOM. AT THIS TIME, PERMOBIL HAS NOT BEEN PROVIDED WITH ANY INFORMATION AS TO THE LENGTH OF THE PORTABLE RAMP, NOR THE HEIGHT OF RISE THE RAMP WAS BEING USED IN ORDER TO CALCULATE THE ANGLE OF DECENT AT THE TIME OF THE INCIDENT. THE DEVICE MANUAL WARNS USERS NOT TO DRIVE THE WHEELCHAIR ON SLOPES STEEPER THAN 10° AND TO USE CAUTION ON SLOPES STEEPER THAN 6°. THE DEVICE MANUAL ALSO STATES THAT SUPPORT WHEELS MUST NOT BE REMOVED IF EQUIPPED AT MANUFACTURE. PERMOBIL WILL CONTINUE WITH THE INVESTIGATION, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING THAT THE END-USER WAS MANEUVERING THEIR F3 CORPUS DOWN A PORTABLE RAMP FROM A RESIDENCE WHEN THE DEVICE TIPPED OVER FORWARD AND LANDED ATOP THE END-USER. THIS REPORTEDLY RESULTED IN SERIOUS INJURIES EVENTUALLY LEADING TO DEATH THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319374 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL INC. F3 N/A 17330818676433

    Patients

    Seq Age Sex Outcome Treatment
    1