BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M3

    MDR report key: 11247436 · Received January 28, 2021

    Report

    Report Number
    1221084-2021-00002
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    June 25, 2020
    Report Date
    January 29, 2021
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818345674
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL LEGAL COUNSEL RECEIVED CORRESPONDENCE FROM THE END-USER'S LEGAL REPRESENTATION WHERE IT WAS ALLEGED THE FOOTREST HAVING SUDDENLY AND INEXPLICABLY FALLEN OFF RESULTING IN THE END-USER HAVING SUSTAINED UNDISCLOSED SERIOUS AND PERMANENT INJURIES TO THEIR LEFT FOOT AND LEG. WITH THE LIMITED INFORMATION RECEIVED THUS FAR, PERMOBIL IS UNABLE TO CONFIRM A SPECIFIC FAILURE; THEREFORE, A DETERMINATION AS TO POTENTIAL ROOT CAUSE CANNOT BE MADE AT THIS TIME. PERMOBIL IS ATTEMPTING TO ESTABLISH CONTACT WITH THE CLIENTS COUNSEL IN EFFORTS TO OBTAIN A MORE DEFINED DESCRIPTION OF THE INJURIES ALLEGED TO HAVE BEEN SUSTAINED, AND TO ACQUIRE A BETTER UNDERSTANDING TO THE ALLEGED FAILURE AND THE CIRCUMSTANCES SURROUNDING THE EVENT. UPON THE RECEIPT OF ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PERMOBIL RECEIVED CORRESPONDENCE FROM THE END-USER'S LEGAL REPRESENTATIVE WHERE IT WAS ALLEGED THE FOOTREST FOR THE DEVICE INEXPLICABLY FELL OFF, RESULTING IN SERIOUS AND PERMANENT INJURIES TO THE END-USERS LEFT FOOT AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140990 PERMOBIL M3 POWERED WHEELCHAIR ITI PERMOBIL INC. M3 N/A 17330818345674

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization