BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEATHERLIGHT WALKER

    MDR report key: 1346487 · Received March 17, 2009

    Report

    Report Number
    1056127-2008-00004
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    May 31, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S FALL WAS DUE TO HIS CONDITION AND WAS NOT DUE TO A PROBLEM WITH THE WALKER. THE PATIENT'S WIFE FELT THAT THE LACERATION WAS CAUSED BY ONE OF THE BOLT HEADS ON THE INSIDE OF THE WALKER, BUT NEITHER THE PATIENT NOR THE PATIENT'S WIFE KNEW EXACTLY WHERE ON THE WALKER THE PATIENT LACERATED HIMSELF. WALKER WAS NOT RETURNED BECAUSE PATIENT WANTED TO CONTINUE USE. ESSENTIAL MEDICAL SUPPLY HAS SOLD ALL WALKERS OF THE SAME DESIGN AND SPECIFICATIONS AND THIS IS THE FIRST REPORT OF THIS TYPE OF INCIDENT. THIS MODEL OF WALKER HAS ALWAYS USED PLASTIC DUST CAPS ON THE OUTSIDE OF THE AXLE BOLTS TO PROTECT FURNITURE AND DOORS FROM BEING MARRED; HOWEVER, THE INSIDE BOLTS HAVE ROUNDED EDGES DESIGNED TO REDUCE ANY POTENTIAL HARM TO THE PATIENT. IT IS OUR CONCLUSION THAT THE INCIDENT IN QUESTION WAS NOT A RESULT OF A MALFUNCTION OR DESIGN FLAW. REPORT INITIATED FOLLOWING FDA AUDIT.

    Description of Event or Problem · 1

    PATIENT WAS STANDING IN FRONT OF SINK WHEN HIS KNEES GAVE OUT. PATIENT'S WIFE CLAIMED THAT THE PATIENT FELL UNDER THE WALKER AND LACERATED HIS LEG ON SCREWS OR OTHER PARTS OF WALKER. WALKER WAS ON TOP OF HIM WHEN PARAMEDICS CAME. FALL WAS NOT DUE TO WALKER PROBLEM. PATIENT WAS ON THE GROUND ABOUT FIFTEEN OR TWENTY MINUTES BEFORE MEDICS CAME AND PICKED HIM UP. PATIENT RECEIVED 10 OR 12 STITCHES IN HIS LEG, DUE TO THE LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEATHERLIGHT WALKER WALKER, MECHANICAL ITJ ESSENTIAL MEDICAL SUPPLY, INC. W1650

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention