BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 2192828 · Received July 10, 2006

    Report

    Report Number
    1034630-2007-00002
    Event Type
    Malfunction
    Date Received
    July 10, 2006
    Date of Event
    June 28, 2006
    Report Date
    July 10, 2006
    Manufacturer
    A&E
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED TO SUNRISE CUSTOMER SVC VIA A PHONE CALL FROM END USER ON (B)(6) 2006. END USER STATES SHE HAS A ROLLING WALKER WITH WHEELS, BASKET AND SEAT. END USER STATES THAT SHE WAS SITTING IN THE SEAT ON THE WALKER AT HER HOME AND THE WHEEL CAME OFF AND SHE FELL TO THE FLOOR HITTING HER HEAD. SHE STATES THAT SHE DID NOT SEEK MEDICAL TREATMENT. SHE ALSO STATES THAT THE OTHER WHEEL ON THE FRONT OF THE WALKER LOOKS LOOSE. THE UNIT HAS NOT BEEN RECEIVED FOR EVAL BY SUNRISE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN ECONO ROLLING WALKER ALUMINUM ITJ A&E 07886G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other