BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 4932693 · Received July 16, 2015

    Report

    Report Number
    8022077-2015-00005
    Date Received
    July 16, 2015
    Date of Event
    August 27, 2014
    Report Date
    July 15, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMANT WAS CONTACTED BY OUR REGULATORY DEPARTMENT. A REPLACEMENT UNIT WAS SENT TO THE GENTLEMEN AT HIS HOME ADDRESS. WE INVESTIGATED THE DESIGN OF PASSED PRODUCT REVISIONS 4.0/4.5/4.8/5.0, THE QC RECORDS AND ALSO THE COMPLAINTS WE HAVE RECEIVED. THIS WALKER/ROLLATOR WAS MANUFACTURED IN 2009. THE ROLLATOR WAS A REV 4.0. THE 4.5/4.8/5.0 ROLLATOR HAS IMPROVED FRONT WHEEL DESIGN AND ALSO REDUCE THE HOLES ON THE FRAME TO REDUCE THE RISK. REV 4.0/4.5/4.8/5.0 ROLLATORS HAVE ALL PASSED THE ISO STANDARD. THE 2009 ROLLATOR HAS BEEN USED FOR 5 YEARS AND WAS PASSED ONTO A SECOND USER BEFORE THE INCIDENT OCCURRED. THE RATE OF COMPLAINT IS ABOUT 0.1%. SOME OF THE COMPLAINTS WE CANNOT DO THE INVESTIGATION BECAUSE THE UNIT IS NOT RETURNED TO US. THE ROLLATOR IS MADE FOR WALKING AND SITTING. HOWEVER, SOME CUSTOMERS ALSO USE IT AS A TRANSPORT CHAIR (WARNINGS ON THE PRODUCT DISALLOW THE USE OF THE PRODUCT AS A METHOD OF TRANSPORT). THIS IS ALSO A REASON FOR DEFECTS.

    Description of Event or Problem · 1

    CLAIMANT WAS WALKING THROUGH THE HOUSE WITH THE UNIT, WHEN THE WALKER BROKE AND HE FELL DOWN. HE HURT HIS RIGHT ARM AND SHOULDER. HE WENT TO THE HOSPITAL TO MAKE SURE THAT HIS ARM WASN'T BROKEN. NO AMBULANCE WAS REQUIRED. THE CLAIMANT HAS OWNED THE UNIT FOR APPROXIMATELY 1 YEAR. HOWEVER, HE HAS ORIGINALLY PURCHASED IT USED FROM ANOTHER PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463636 HUGO HUGO ELITE WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization