BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5210411

    MDR report key: 5210411 · Received November 9, 2015

    Report

    Report Number
    5210411
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 19, 2015
    Report Date
    October 29, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HUMAN FACTORS ISSUE WITH MIDLAND MFG CO ELECTRIC BARIATRIC STAND-IN TABLE. DR WAS CALLED TO EVALUATE PATIENT IN THE THERAPY GYM. PATIENT WAS STANDING WITH THERAPIST USING A STEADYING PLATFORM. HER RIGHT GREAT TOE WAS UNDERNEATH THE PLATFORM, AND WHEN SHE WENT TO MOVE IT, THE PROXIMAL HALF OF HER GREAT TOE NAIL WAS SHEARED OFF. THERE WAS AT FIRST SIGNIFICANT BLEEDING, HOWEVER, WITH COMPRESSION BY NURSING AND THERAPIST, THIS RESOLVED. WHEN DR CAME TO EXAMINE THE NAIL, THERE WAS CLEARLY BLOOD PRESENT, HOWEVER, ACTIVE BLEEDING APPEARED TO HAVE CEASED FOR THE TIME BEING. THE DISTAL HALF OF THE NAIL WAS STILL INTACT, THOUGH LOOKED FRIABLE. NO SIGNS OF INFECTION. CONTINUED MONITORING. PAIN IS CONTROLLED. CLINICAL ENGINEERING RECOMMENDATION IS TO HAVE PATIENTS WEAR SHOES WHEN USING THE TABLE AND TO PAINT/TAPE THE BASE OF THE TABLE WHERE PATIENTS PUT THEIR FEET TO BE CAREFUL OF THE GAP THAT EXISTS AND NOT TO INADVERTENTLY HURT THEIR TOE(S).

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other