BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M300 CORPUS 3G

    MDR report key: 3122473 · Received May 13, 2013

    Report

    Report Number
    1221084-2013-00009
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    PMA / PMN Number
    K103477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: MFR INSPECTED THE WHEELCHAIR AND FOUND THAT IT WAS OPERATING NORMALLY AND NOTHING WAS OUT OF SPECIFICATION. IT APPEARS THAT USER ERROR IN DRIVING THE WHEELCHAIR CAUSED THE INCIDENT.

    Description of Event or Problem · 1

    USER RAN INTO GUARD RAILS WITH HER NEW WHEELCHAIR AND SUFFERED A BROKEN LEG. AFTER INVESTIGATION, IT APPEARS THAT THIS ELDERLY USER ACCIDENTALLY RAN INTO GUARD RAILS WHILE USING HER WHEELCHAIR. MFR INSPECTED THE WHEELCHAIR AND COULD NOT FIND ANYTHING WRONG WITH THE OPERATION OF THE WHEELCHAIR. THE WHEELCHAIR WAS FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210813 PERMOBIL M300 CORPUS 3G POWER WHEELCHAIR ITI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention