BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 4943505 · Received July 17, 2015

    Report

    Report Number
    8022077-2015-00007
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 16, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE TRIED CALLING THE CLAIMANT 4 TIMES AND WAS ONLY ABLE TO LEAVE A MESSAGE. NO MORE INFORMATION COULD HAVE BEEN PROVIDED TO QUALITY ASSURANCE DEPARTMENT FOR FURTHER INVESTIGATION. THE PRODUCT WAS NEVER RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    CLAIMANT WAS SITTING IN THE ROLLING WALKER AND THE WHEEL FELL OFF. THIS OCCURRED IN HER BATHROOM. SHE HIT HER HEAD AND SPENT A COUPLE OF DAYS IN THE HOSPITAL. NO AMBULANCE WAS REQUIRED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465405 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization