BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M3

    MDR report key: 12842872 · Received November 19, 2021

    Report

    Report Number
    1221084-2021-00039
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    February 1, 2021
    Report Date
    January 25, 2022
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818345674
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL IS UNABLE TO CONFIRM A DEVICE MALFUNCTION OCCURRED AS ALLEGED DUE TO THE DEVICE NOT BEING MADE AVAILABLE, BY THE END-USER, FOR INSPECTION/EVALUATION. NUMEROUS ATTEMPTS HAVE BEEN MADE IN ATTEMPT TO EVALUATE THE DEVICE, BUT WITH EACH SCHEDULED ATTEMPT THE APPOINTMENT WAS CANCELLED BY THE END-USER. AS THE DEVICE IS NOT BEING MADE AVAILABLE, PERMOBIL CANNOT REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE OF THE RPEORTED EVENT WITHOUT SPECULATION. PERMOBIL WILL CONTINUE TO MONITOR AND IF ANY NEW INFORMATION IS PROVIDED, THE CASE INVESTIGATION WILL BE RE-OPENED AND A FOLLOW-UP REPORT SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORT PROVIDED TO PERMOBIL FROM THE END-USER CLAIMS WHILE ATTEMPTING TO ENTER THEIR APARTMENT, THEY DROVE THE WHEELCHAIR INTO THE FRAME OF THE APARTMENT DOOR, RESULTING IN A BROKEN FINGER. THE END-USER REPORTS THIS EVENT OCCURRED APPROXIMATELY 8-9 MONTHS PRIOR BUT HAD NOT REPORTED TO PERMOBIL UNTIL JUST RECENTLY. THE END-USER CLAIMS THE WHEELCHAIR "WIGGLES" AND THAT IS WHAT CAUSED THEM TO DRIVE INTO THE DOOR FRAME. THE END-USER CLAIMS HAVING CONTACTED THEIR SERVICE PROVIDER NUMEROUS TIMES, BUT DUE TO COVID RESTRICTIONS, THEY NEVER RESPONDED. PERMOBIL CONTACTED THE END-USER'S SERVICE PROVIDER AND WAS INFORMED THEY WOULD SCHEDULE TO EVALUATE THE DEVICE. AT THE TIME, PERMOBIL IS UNABLE TO CONFIRM A PRODUCT MALFUNCTION AS THE SERVICE PROVIDER HAS BEEN UNABLE TO EVALUATE THE DEVICE DUE TO SCHEDULING ISSUES WITH THE END-USER. PERMOBIL WILL CONTINUE TO MONITOR AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    REPORTS HAVING BROKEN ONE OF HIS FINGERS AFTER HAVING DRIVEN HIS DEVICE INTO A DOOR FRAME WHILE ATTEMPTING TO ENTER HIS APARTMENT. REPORT INDICATES THE END-USER HAVING SUSTAINED A BROKEN FINGER BECAUSE OF THE IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742344 PERMOBIL M3 POWERED WHEELCHAIR ITI PERMOBIL INC. M3 N/A 17330818345674

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other