BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 25153642 · Received May 12, 2026

    Report

    Report Number
    1221084-2026-00005
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 12, 2026
    Manufacturer
    PERMOBIL INC
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT PROVIDED BY PERMOBIL AB INDICATES WHILE THE END-USER WAS TRAVERSING ON A DOWNWARD SLOPE WHILE DRIVING AT SPEED, IT WAS REPORTED THE DEVICE SUDDENLY AND WITHOUT WARNING LOST POWER AND STOPPED ABRUPTLY. THE END-USER WAS REPORTED TO HAVE BEEN WEARING A POSITIONING BELT, AND WHEN THE CHAIR STOPPED, THE FORWARD MOMENTUM CAUSED THE DEVICE TO TIP OVER FORWARD WITH THE USER REMAINING IN THE SEATING. THIS ACTION REPORTEDLY LET TO THE END-USER SUSTAINING BI-LATERAL TIBIA AND FIBULA FRACTURES, AND FRACTURES OF UNSPECIFIED BONES IN THEIR FEET. THIS EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 1.5 YEARS PRIOR WHEN THE END-USER WAS ON VACATION IN SPAIN. IT WAS REPORTED THE DEVICE WAS TAKEN TO A LOCAL SERVICE PROVIDER WHERE IT WAS DIAGNOSED AS HAVING A DAMAGED JOYSTICK CABLE. IT WAS NOT RELAYED AS TO POSSIBLE CAUSE FOR THE CABLE TO HAVE FAILED, ONLY THAT IT WAS DAMAGED AND WHEN REPLACED, THE DEVICE WAS RESTORED TO NORMAL OPERATION. DUE TO THE AGE OF THE EVENT OCCURRENCE AND PERMOBIL NOT HAVING THE OPPORTUNITY TO INSPECT THE DEVICE OR COMPONENTS, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE CAUSE WITHOUT SPECULATION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING WHILE THE END-USER WAS DRIVING THEIR DEVICE ON A DOWNWARD SLOP, THE DEVICE REPORTEDLY STOPPED WITHOUT NOTICE. REPORTS CLAIM THE END-USER WAS TRAVELING AT SPEED, AND WHEN THIS OCCURRED IT ALLOWED THE DEVICE TO TIP OVER FORWARD WITH THE END-USER REMAINING IN THE SEATING. THIS RESULTED IN THE DEVICE FALLING ATOP THE END-USER WHERE THEY WERE REPORTED TO HAVE SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546832 PERMOBIL F5 CORPUS POWERED WHEELCHAIR ITI PERMOBIL INC F5 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other