BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE PYRAMID CANE

    MDR report key: 2923268 · Received September 29, 2006

    Report

    Report Number
    1000282279-2006-00011
    Event Type
    Malfunction
    Date Received
    September 29, 2006
    Date of Event
    September 1, 2006
    Report Date
    September 5, 2006
    Manufacturer
    R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    KHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER SENT PICTURES OF THE DEVICE TO THE DISTRIBUTOR FOR EVAL. IT APPEARS THAT THE OUTSIDE LEFT LEG BROKE WHERE THE CROSSBAR IS ATTACHED. WE (THE DISTRIBUTOR OF THE DEVICE) REQUESTED THAT USER RETURN THE DEVICE FOR EVAL; HOWEVER, THE USER DID NOT WANT TO RETURN IT. WE ARE UNABLE TO FURTHER DETERMINE THE CAUSE OF THE MALFUNCTION AT THIS TIME BECAUSE WE DO NOT HAVE POSSESSION OF THE CANE INVOLVED IN THE INCIDENT. NO SIMILAR INCIDENTS WERE REPORTED TO THE MFR. WE WILL RETURN THE DEVICE TO THE MFR FOR TESTING IF IT IS RETURNED BY THE USER. IN REVIEWING PHOTO TAKEN BY THE DEALER AND SENT TO US, BOTH OUTSIDE LEGS OF THE CANE ARE BENT INWARD, TENDING TO INDICATE THAT AT LEAST ONE LEG WAS WEDGED OR CAUGHT BEFORE THE FALL. NO CORROBORATING EVIDENCE IS AVAILABLE AS USE WAS ALONE IN THE BATHROOM WHEN THE FALL OCCURRED.

    Description of Event or Problem · 1

    ACCORDING TO THE USER'S WIFE, THE INCIDENT OCCURRED AT AROUND 8:30AM ON FRIDAY (B)(6) 2006. THE USER WAS ENTERING THE BATHROOM AND SHE HEARD A NOISE THAT SOUNDED LIKE A FALL. WHEN SHE ENTERED THE BATHROOM, SHE FOUND THE USER HAD FALLEN TO THE FLOOR AND THE BROKEN CANE WAS NEXT TO HIM. THE USER CLAIMS THAT HE FELL WHEN THE OUTSIDE LEFT LEG BROKE. THE USER WAS VERY DAZED BY THE INCIDENT AND HAD TO LIE ON THE FLOOR FOR APPROXIMATELY 15 MINUTES. THE USER WAS TAKEN TO THE DOCTOR BY HIS WIFE. THE USER'S WIFE CLAIMED THAT HE WAS BRUISED AND CUT AS A RESULT OF THE INCIDENT, BUT PROVIDED NO PHYSICAL EVIDENCE TO SUPPORT THE CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE PYRAMID CANE KHY CANE, SAFETY WALK KHY R. POON MEDICAL PRODUCTS CO., LTD. W1300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR