BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 829548 · Received March 15, 2007

    Report

    Report Number
    MW1042277
    Event Type
    Other
    Date Received
    March 15, 2007
    Date of Event
    November 15, 2006
    Report Date
    March 15, 2007
    Manufacturer
    DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 11/15/906, CAREGIVER CALLED IN, VIA TELEPHONE, REPORTING THAT AN END-USER, HER AUNT, HAD FALLEN WHILE USING HER ROLLATOR. THE CAREGIVER REPORTED THAT WHILE USING THE ROLLATOR, SHE ROLLED BACK AND THE RIGHT FRONT WHEEL BROKE. THE END-USER, AS RECOUNTED BY THE CAREGIVER, ALLEGEDLY FELL AND HIT HER HEAD AND HIP ON A WALL. PER THE CAREGIVER, THE END-USER WENT TO THE HOSP AND REC'D A CAT SCAN. REPORTED DIAGNOSIS: CONTUSION AND ABRASION ABOVE HER RIGHT EYE AND SCALP, A HEMATOMA ON HER RIGHT HIP AND LOWER ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ROLLATOR ITJ DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD RJ4300G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other