BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN

    MDR report key: 441171 · Received February 5, 2003

    Report

    Report Number
    2020334-2003-00001
    Event Type
    Other
    Date Received
    February 5, 2003
    Report Date
    February 5, 2003
    Manufacturer
    SUNRISE MEDICAL, PCP DIVISION
    Product Code
    ITJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS CURRENT USER HAD USED THIS ROLLING WALKER FOR THE LAST TWO YEARS. ON THIS OCCASION IT WAS REPORTED THAT THEY WERE SEATED ON THE WALKER WHEN THE LEFT SIDE OF THE WALKER COLLAPSED. USER HURT THEIR LEFT LEG AND SPENT FOUR WEEKS IN HOSP. AFTER THE FALL WALKER WAS INSPECTED BY A FAMILY MEMBER AND FOUND TO HAVE TWO BOLTS MISSING ON THE LEFT SIDE OF THE WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN WALKER ITJ SUNRISE MEDICAL, PCP DIVISION 7875 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization