BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO

    MDR report key: 5404347 · Received January 18, 2016

    Report

    Report Number
    8022077-2016-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2016
    Date of Event
    December 24, 2015
    Report Date
    January 13, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO AMBULANCE WAS REQUIRED AT THE TIME OF INCIDENT. THE FATHER-IN-LAW FELL ONTO THE CONCRETE BUT THERE WAS NO SERIOUS INJURY. WE SHIPPED A NEW ROLLATOR TO THE CUSTOMER AND REQUESTED THAT THE DEFECTIVE UNIT BE SENT TO US FOR INVESTIGATION. A F/U REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CLAIMANT'S FATHER-IN-LAW WAS SITTING IN HIS HUGO WALKER ON THE EVENING OF (B)(6) 2015 WHEN ONE OF THE LEGS SHEARD OFF, CAUSING HIM TO FALL ONTO THE CONCRETE IN THE DRIVEWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34357 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other