BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 23715468 · Received December 4, 2025

    Report

    Report Number
    1221084-2025-00016
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    October 22, 2025
    Report Date
    December 4, 2025
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING THE END-USER HAVING BEEN FOUND FALLEN FORWARD IN THE WHEELS WHILE SEATING WAS IN A FULL STANDING POSITION. REPORT INDICATED THE END-USERS KNEES AND LEGS WERE SECURED VIA THE KNEE BLOCK ASSEMBLY, BUT THE INCORPORATED CHEST BAR WAS NOT IN PLACE, AND THERE WAS NO POSITIONING BELT. THE END-USER WAS TAKEN TO THE LOCAL HOSPITAL FOR EVALUATION WHERE IT WAS DETERMINED THEY HAD SUSTAINED BI-LATERAL FRACTURES TO TIBIA AND FIBULA. THE DEVICE WAS EVALUATED BY PROVIDER WHERE IT WAS DETERMINED TO BE FULLY OPERATIONAL WITH NO SIGNS OF A MALFUNCTION HAVING OCCURRED. PROVIDER REPORTS HAVING REMOVED THE STAND FUNCTION FROM THE SEATING MENU IN THE JOYSTICK, AND MOVED SEAT FUNCTION CONTROL SWITCHBOX TO THE BACK OF THE CHAIR FOR ATTENDANT CONTROL FOR STAND FUNCTION. DEVICE WAS RETURNED TO THE END-USER WITH NO FURTHER REPORTS BEING RECEIVED.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING THE END-USER WAS FOUND BY CARETAKERS IN THEIR WHEELCHAIR, RAISED IN THE STANDING POSITION AND THAT THE USER'S UPPER BODY AND THIGHS WERE LEANING FORWARD. REPORTS INDICATE THE END-USER HAD SUSTAINED INJURIES REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727521 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization