BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35-PST PROFLEXX

    MDR report key: 1713866 · Received May 28, 2010

    Report

    Report Number
    1523574-2010-00003
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    November 17, 2009
    Report Date
    May 21, 2010
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL INCIDENT REPORT OCCURRED ON (B)(6) 2010. FOLLOWING WAS THE REPORT RECEIVED AT THAT TIME. THE CREW TOOK THE PATIENT INTO THE HOSPITAL AND WHEN THEY WERE WALKING THROUGH THE ER, THEY WENT THROUGH TWO SLIDING DOORS. THEY WENT THROUGH THE FIRST SET OF DOORS THE COT WAS LIFTED OVER A TALL DOOR JAM WITH NO ISSUE. AS THEY WERE GOING THROUGH THE SECOND SET OF DOORS, THE FRONT LEFT WHEEL CAME OFF THE UNIT. THE FOOT END OF THE COT WENT TO THE GROUND. PATIENT WAS CHECKED FOR INJURIES. A BRUISE OVER THE EYE AND SOME SHOULDER PAIN WAS NOTED BY THE ATTENDANTS. ON (B)(6), 2010, ADDITIONAL INFORMATION WAS OBTAINED. THE PATIENT SUSTAINED A BROKEN THUMB AND STILL HAD SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35-PST PROFLEXX 35-PST PROFLEXX FPO FERNO-WASHINGTON, INC. 35-PST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN