BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 18877282 · Received March 11, 2024

    Report

    Report Number
    1221084-2024-00005
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 4, 2024
    Report Date
    March 11, 2024
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT VIA THE END-USERS MOTHER OF AN EVENT HAVING OCCURRED WHERE THE END-USER HAD SUSTAINED A FRACTURED TIBIA WHILE USING THE DEVICES STAND FUNCTION. THE REPORTER CLAIMS THE DEVICE DID NOT MALFUNCTION, BUT RATHER SUGGESTS THE END-USER'S CAREGIVERS HAD OVER TIGHTENED THE KNEE SUPPORT BLOCKS IN THAT WHEN THE END-USER STOOD, THE FORCE PRESSURE OF THE KNEE BLOCK ASSEMBLY WAS TOO GREAT AND THIS LED TO A FRACTURE OF THE LEFT TIBIA. THE DEVICE WAS INSPECTED AFTERWARDS BY LOCAL REPRESENTATIVE, AND WAS FOUND TO REMAIN FULLY OPERATIONAL. HOWEVER, IT WAS NOTED THE KNEE BLOCK ASSEMBLY WHEN STOOD HAD VERY LITTLE CLEARANCE WHICH WOULD CONFIRM THE ASSEMBLY AS BEING OVERTIGHTENED FOR THAT SPECIFIC USER NEEDS. REPRESENTATIVE PROVIDED THE USERS FAMILY AN OPTION OF DIFFERENT STYLE KNEE SUPPORT THAT IS LESS SUSCEPTIBLE FOR INADVERTENT ADJUSTMENTS TO BE MADE. THE DHR WAS REVIEWED, AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING WHILE THE END-USER WAS OPERATING THE STAND FUNCTION, THE END-USER REPORTEDLY SUSTAINED A FRACTURE TO THEIR LEFT TIBEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464705 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization