BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2912202 · Received January 11, 2013

    Report

    Report Number
    1531186-2013-00156
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 11, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE UNKNOWN MODEL ROLLATOR BRAKES FAILED TO ENGAGE WHILE SHE WAS TRYING TO REACH A SODA OUT OF THE REFRIGERATOR. AS A RESULT, SHE FELL, THE FRAME WELD BROKE, THE BACK WHEEL BENT INWARDS, AND SHE ALLEGEDLY HURT HER ARM. NO MEDICAL ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL REVIEW THIS FILE, AND A SUPPLEMENTAL MDR REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18064 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 Other