BEUDAMED
    FDA Adverse Event Summary report: N

    HUGO

    MDR report key: 5799870 · Received July 15, 2016

    Report

    Report Number
    8022077-2016-00044
    Date Received
    July 15, 2016
    Report Date
    July 15, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE HERE WAS LIKELY INCORRECT ASSEMBLY, AS WELL AS POTENTIALLY EXCEEDING THE WEIGHT CAPACITY. WE HAVE RECEIVED A FEW COMPLAINTS THROUGHOUT (B)(6) OF PEOPLE INCORRECTLY INSTALLING THE FRONT WHEELS, AND IT IS ALWAYS BECAUSE THEY DON'T CHECK THE INSTRUCTIONS WHICH SHOW THE FRONT WHEELS NEEDING TO BE COMPLETELY INSTALLED AND THEN SECURED WITH THE ECLIPS. THEY WILL INSTALL THE FRONT WHEELS ONLY PARTIALLY INTO THE FRAME TUBING, AND WITH EXCESSIVE WEIGHT APPLIED THE TUBING THEN HAS A RISK OF BENDING, ALTHOUGH IN THIS CASE IT ALLEGEDLY SHEARED. OUR INSTRUCTIONS SHOW WITH IMAGES HOW TO INSTALL THE WHEELS PROPERLY, AND WE HAVE ALSO FILMED A FULL PRODUCT ASSEMBLY VIDEO TO HELP AS WELL ON OUR WEBSITE. THE SIDEKICK ROLLATOR CAN WITHSTAND AT LEAST 150% OF THE ISO FATIGUE OBJECTIVES. THUS WE DO NOT BELIEVE IT SHEARED WITHIN A FEW HOURS IF IT WAS ASSEMBLED CORRECTLY. THE END-USER FELL BUT WAS NOT INJURED. THIS CLAIM IS NOW CLOSED.

    Description of Event or Problem · 1

    ONE OF OUR CUSTOMERS REPORTED THE FOLLOWING INCIDENT TO US: WITHIN HOURS AFTER BUYING THE ROLLING WALKER, THE FRONT WHEEL SHEARED OFF WHEN PATIENT SAT ON THE SEAT. BRAKES WERE SET AND HE FELL TO THE FLOOR. THANKFULLY HE WAS SHAKEN BUT NOT HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452032 HUGO HUGO MOBILITY SIDEKICK SIDE-FOLDING ROLLATOR WALKER WITH SEAT, TANGERINE ITJ AMG MEDICAL INC. 700-983

    Patients

    Seq Age Sex Outcome Treatment
    1