BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2082784 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00173
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    December 16, 2009
    Report Date
    April 28, 2011
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER ALLEGEDLY PURCHASED A USED WALKER IN THE PAST AND THE BRAKES AT THAT TIME WERE NOT WORKING. THE CONSUMER STATED WHILE USING THE ROLLATOR, THEY FELL OVER THE TOP OF THE ROLLATOR AND ALLEGES THE INCIDENT OCCURRED IN (B)(6) 2009, BUT DID NOT REPORTED UNTIL (B)(6) 2011. THE CONSUMER STATED THEY HAVE BEEN BUSY AND NOT ABLE TO REPORT THIS INCIDENT SOONER. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN/IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. THE CONSUMER ALLEGEDLY HAD BLEEDING TRAUMA TO HER CHEST. MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES, THE WHEELLOCKS DID NOT HOLD, CAUSING HER TO GO OVER TOP OF THE WALKER AND LAND ON THE LEFT SIDE OF HER CHEST ON THE CURB. SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65100-JR QT071112

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R