BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN WALKER

    MDR report key: 317143 · Received February 21, 2001

    Report

    Report Number
    2020334-2001-00004
    Event Type
    Other
    Date Received
    February 21, 2001
    Report Date
    February 21, 2001
    Manufacturer
    SUNRISE MEDICAL/PCP DIVISION
    Product Code
    ITJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END USER FELL BACKWARDS WHILE USING THE WALKER. USER HAD CONTUSIONS TO THE USERS BACK, AND SPENT FIVE DAYS IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6654 GUARDIAN WALKER PATIENT WALKER ITJ SUNRISE MEDICAL/PCP DIVISION 30755P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O