BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELENKER WALKER, MECHANICAL

    MDR report key: 16733905 · Received April 12, 2023

    Report

    Report Number
    MW5116610
    Event Type
    Other
    Date Received
    April 12, 2023
    Date of Event
    December 23, 2022
    Report Date
    April 12, 2023
    Manufacturer
    FUZHOU FEIWO TRADING CO., LTD.
    Product Code
    ITJ
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT ABOUT HIS ROLLATOR THAT BROKE AFTER 3 MONTH'S USE. HE SAID IT WAS BOUGHT FROM AMAZON ON SEPTEMBER 23, 2022. HE USED IT FOR 3 MONTHS FINE AND ONE DAY HE WAS WALKING ON THE STREET, AND THE WHEEL FELL OUT AND HE FELL ON HIS KNEES. HE SAID HE WAS NOT HURT. HE CONTACTED AMAZON BUT THEY REFUSED TO TAKE IT BACK SINCE HE USED IT. HE THEN CONTACTED THE MANUFACTURER, AND A LADY TOLD HIM TO TAKE A PICTURE AND SEND IT TO HER. AFTER HE DID THAT, THEY SENT HIM TWO REPLACEMENT WHEELS. HE SAID HE HIRED SOMEONE TO INSTALL THE WHEELS AND STARTED USING THE ROLLATOR. HE SAID LAST FRIDAY THE SAME THING, HAPPENED, THE WHEELS FELL OUT AND HE FEEL AGAIN BUT HE WAS NOT HURT THAT MUCH. HE STATED HE TRIED TO CONTACT THE MANUFACTURER ABOUT 10 TIMES, AND SOMETIMES HE WAS TOLD SOMEONE WILL GET BACK TO HIM OTHER TIMES, NO ONE ANSWERS. HE ALSO WANTS TO KNOW IF HIS DEVICE HAS BEEN RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250901 ELENKER WALKER, MECHANICAL WALKER, MECHANICAL ITJ FUZHOU FEIWO TRADING CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male