BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5

    MDR report key: 8795917 · Received July 16, 2019

    Report

    Report Number
    1221084-2019-00032
    Event Type
    Injury
    Date Received
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED REPORT INDICATING AN INJURY HAVING OCCURRED TO THE END-USER AS THEY WERE OPERATING THEIR MOBILITY DEVICE. REPORT INDICATED THE END-USER SUFFERED FRACTURES TO BOTH LEFT AND RIGHT TIBIA'S, BUT REPORT DID NOT GO INTO DETAIL AS TO THE CIRCUMSTANCES SURROUNDING THE EVENT NOR THE PROBABLE CAUSE OTHER THAN THEY BELIEVE THE DEVICE MALFUNCTIONED SOME HOW TO HAVE CAUSED IT. SINCE RECEIPT OF REPORT, BOTH PERMOBIL AND THE SERVICE PROVIDER HAVE BEEN ATTEMPTING TO CONTACT THE END-USER AND THEIR FAMILY IN ORDER TO GATHER MORE INFORMATION AS TO THE CIRCUMSTANCES SURROUNDING THE CLAIM AND TO REQUEST ACCESS TO THE DEVICE FOR EVALUATION. AT THIS POINT, PERMOBIL HAS BEEN UNABLE TO MAKE CONTACT WITH ANYONE WITH KNOWLEDGE OF THE ALLEGED EVENT. PERMOBIL WILL CONTINUE TO INVESTIGATE AND UPON RECEIPT OF NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT ALLEGING AN UNDISCLOSED MALFUNCTION HAVING OCCURRED WITH THE DEVICE WHICH CAUSED THE END-USER TO HAVE SUFFERED A BROKEN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590126 PERMOBIL F5 POWERED WHEELCHAIR ITI PERMOBIL INC. F5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization