BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDE STYLE HEMI ONE ARM WALKER 10240-1

    MDR report key: 6916085 · Received October 5, 2017

    Report

    Report Number
    MW5072612
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 3, 2017
    Manufacturer
    DRIVE MEDICAL
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY NEIGHBOUR'S WALKER BROKE WHILE HE WAS USING IT AND HE SUSTAINED TWO CUTS AND HIS WIFE HAD TO CALL FOR ASSISTANCE. I TOLD HIS WIFE I WOULD CONTACT THE COMPANY ABOUT IT. I LEFT THE BELOW MESSAGES ON THEIR WEBSITE AT (B)(4) TWO DAYS AGO BUT HAVE NOT HEARD BACK FROM THEM. HELLO - I'M WRITING ABOUT MY NEIGHBOUR'S 10240-1 SIDE STYLE HEMI ONE ARM WALKER. THE BACK LEFT LEG BROKE OFF IN USE, RESULTING IN A FALL AND A VISIT BY A FIRE TRUCK, THOUGH FORTUNATELY (B)(6) WAS NOT SERIOUSLY INJURED. HIS WIFE GAVE ME THE WALKER AND THE BROKEN LEG AND I TOLD HER I WOULD CONTACT YOU ABOUT THE FAILURE. I'M AN AEROSPACE ENGINEER AND MY GUESS IS THE FAILURE MODE WAS ALUMINIUM FATIGUE. THE LEG WAS APPARENTLY LOADED IN PROBABLY SOME THOUSANDS OF BENDING CYCLES OVER THE PAST 3-4 YEARS AND FAILED AT ONE OF THE ADJUSTMENT HOLES WHERE STRESS WAS AT A MAXIMUM. THIS WAS APPARENTLY THE RESULT OF A DESIGN FLAW, IN THAT THE ADJUSTMENT HOLES SHOULD HAVE BEEN POSITIONED ALONG THE SIDES OF THE TUBE RATHER THAN ALONG THE FRONT FACE, WHICH SIGNIFICANTLY LOWERED THE ABILITY OF THE TUBE TO RESIST FRONT TO BACK BENDING. FEEL FREE TO HAVE ONE OF YOUR ENGINEERS CONTACT ME TO DISCUSS THE MATTER. I CAN BE REACHED AT (B)(6). HELLO - I WROTE TO YOU SOME MINUTES AGO ABOUT THE STRUCTURAL FAILURE OF MY NEIGHBOUR'S 10240-1 WALKER AND I JUST NOW CHECKED THE (B)(6) REVIEWS FOR IT AND I GET THE IMPRESSION MY NEIGHBOUR GOT HIS ONE SHORTLY AFTER THE MODEL WENT INTO PRODUCTION. IF HIS WALKER DID IN FACT EXPERIENCE A FATIGUE FAILURE THEN THAT INDICATES YOU MAY HAVE A SUBSTANTIAL POPULATION THAT IS ABOUT TO START FAILING. I SUSPECT IMMINENT FAILURE COULD BE DETECTED BY VISUAL INSPECTION. I'M NOT SURE IT WOULD BE COST EFFECTIVE TO REPLACE THE EFFECTED COMPONENTS AND YOU MIGHT HAVE TO REPLACE THE ENTIRE UNIT. IN POSSESSION OF FAILED UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695481 SIDE STYLE HEMI ONE ARM WALKER 10240-1 SIDE STYLE HEMI ONE ARM WALKER 10240-1 ITJ DRIVE MEDICAL 10240-1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other