BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEPSIDER ADULT WALKER

    MDR report key: 2171879 · Received March 10, 2007

    Report

    Report Number
    3006112083-2007-00007
    Event Type
    Injury
    Date Received
    March 10, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 27, 2007
    Manufacturer
    PROFIT COUNTRY ENTERPRISES
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE WALKER LEG WAS BROKEN OFF. IT APPEARS THE LEG WAS SUBJECTED TO AN ABNORMAL LOAD AT AN ANGLE CAUSING THE LEG TO BEND/BREAK. THIS IS NOT CONSISTENT WITH NORMAL USE.

    Description of Event or Problem · 1

    STATEMENT READS "END USER STUMBLED AND FELL UPON THE WALKER CRACKING THE OUTSIDE LEG APPROX THREE QUARTERS OF THE THROUGH." CUSTOMER STATES DID NOT KNOW OF ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEPSIDER ADULT WALKER WALKER ITJ PROFIT COUNTRY ENTERPRISES 07770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other