BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M3

    MDR report key: 10159285 · Received June 16, 2020

    Report

    Report Number
    1221084-2020-00026
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 16, 2020
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818345674
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT PROVIDED TO PERMOBIL CLAIMS AS THE END-USER WAS IN PROCESS OF ENTERING THEIR TRANSPORT VEHICLE, THE DEVICE AND END-USER FELL OFF THE PLATFORM TO THE GROUND BELOW. THIS EVENT REPORTEDLY RESULTED IN THE END-USER SUFFERING A FRACTURED JAW WHEN THE DEVICE FELL OVER ON ITS SIDE. THE END-USER HUSBAND DESCRIBED THE PLATFORM AS NOT BEING CONFIGURED TO RESTRAIN THE PERMOBIL M3 WHICH ALLOWED THE DEVICE TO BECOME UNSECURED. REPORTS PROVIDED TO PERMOBIL FROM THE SERVICE PROVIDER WHO EVALUATED THE DEVICE INDICATE THE DEVICE REMAINS FULLY OPERATIONAL WITH ONLY MINOR DAMAGES SUSTAINED TO THE ARMRESTS AS A RESULT OF THE FALL. ALL REPORTS PROVIDED TO PERMOBIL INDICATE THE DEVICE DID NOT MALFUNCTION OR DEVIATE IN ANY WAY TO HAVE CONTRIBUTED TO THIS EVENT. THE DHR WAS REVIEWED AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS IN PROCESS OF ENTERING THEIR TRANSPORT VEHICLE, THE POWER WHEELCHAIR, WITH END-USER, DROPPED OFF THE PLATFORM CAUSING THE DEVICE TO FALL OVER ON TO ITS SIDE. REPORTS INDICATE THE END-USER SUFFERED INJURIES REQUIRING MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621082 PERMOBIL M3 POWERED WHEELCHAIR ITI PERMOBIL INC. M3 N/A 17330818345674

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization