BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 4943504 · Received July 17, 2015

    Report

    Report Number
    8022077-2015-00006
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    September 4, 2014
    Report Date
    July 16, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE CLAIMANT'S WIFE CALLED OUR CUSTOMER SERVICE DEPARTMENT TO REPORT THE INCIDENT, SHE ADMITTED TO OUR REP THAT HER HUSBAND WAS USING THE UNIT TO ROLL AROUND IN THE KITCHEN. IT IS CLEARLY STATED IN THE INSTRUCTION MANUAL AND THERE ARE WARNING ON VARIOUS PARTS OF THE UNIT TO NOT NAVIGATE THE ROLLING WALKER WHILE SEATED ON THE SEAT. THIS PRODUCT IS NOT TO BE USED AS A TRANSPORT CHAIR. WE SENT A REPLACEMENT ROLLING WALKER TO THE CLAIMANT AND REQUESTED THAT THE DAMAGED UNIT BE RETURNED TO US FOR INVESTIGATION. THE REPLACEMENT WAS SENT OUT ON (B)(6) 2014. ON (B)(6) 2014, OUR REGULATORY DEPARTMENT TRIED TO FOLLOW-UP WITH THE CLAIMANT TO SEE IF THEY HAVE RECEIVED THE REPLACEMENT AND TO COORDINATE THE SHIPMENT BACK TO AMG OF THE BROKEN UNIT. HOWEVER, THERE WAS NO ANSWER AND WE LEFT A VOICEMAIL. ON (B)(6) 2014, AFTER NO RESPONSE BACK FROM THE CLAIMANT, OUR REGULATORY DEPARTMENT CALLED BACK AND LEFT ANOTHER MESSAGE. AS THE CUSTOMER WAS ABLE TO SHIP THE ROLLING WALKER BACK TO US FOR INVESTIGATION, THIS CASE HAS BEEN CLOSED.

    Description of Event or Problem · 1

    WHILE SITTING, THE LEG OF THE UNIT BROKE. CLAIMANT'S WIFE ADMITTED THAT HER HUSBAND WAS USING THE UNIT TO ROLL AROUND IN THE KITCHEN. THE FRONT WHEEL SNAPPED OFF AND THE CLAIMANT SUSTAINED AN INJURY TO HIS LEG. NO AMBULANCE WAS REQUIRED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464765 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization