BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE EXCALIBUR

    MDR report key: 2980772 · Received February 19, 2013

    Report

    Report Number
    1056127-2013-00005
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ZHANGZHOU LEATAI MED INSTRUMENTS CO., LTD
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT ONE FRONT CASTER HAD DETACHED APPROX TWO YEARS AGO. TO THE BEST OF HER MEMORY SHE WAS WALKING IN HER HOME. THERE WAS NO FALL OR INJURY. SHE REPORTED IT TO HER LOCAL (B)(4) DEALER WHO SOLD HER A NEW WALKER. THIS REPORT COMES ABOUT FROM HER RETURNING AGAIN WITH THE SECOND WALKER FOR REPAIR AND ALSO ASKING IF THIS SUBJECT WALKER COULD BE REPAIRED. THE CASTER IS CURRENTLY ATTACHED AND SHOWS SIGNS OF HAVING BEEN LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72867 THE EXCALIBUR ROLLATOR ITJ ZHANGZHOU LEATAI MED INSTRUMENTS CO., LTD LRA-200FBD

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR