BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO

    MDR report key: 5984578 · Received September 28, 2016

    Report

    Report Number
    8022077-2016-00063
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    INP
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE VERIFIED AND TESTED OUR STOCK AND DID NOT SEE ANY CRACKS. WE WILL MONITOR THIS CLOSELY BUT FOR NOW THIS IS AN ISOLATED OCCURRENCE. THE CUSTOMER DID NOT FALL AND THERE WAS NO INJURY. THIS CASE IS NOW CLOSED.

    Description of Event or Problem · 1

    CUSTOMER PURCHASED 2 QUAD PODS AND THEY BROKE A FEW WEEKS LATER.WE SENT THE CUSTOMER NEW QUAD POD TIPS AND THE NEW ONES ALSO STARTED TO FAIL, ONE SIDE IS BROKEN AND IS SPLITTING AWAY AT THE CENTRAL SHAFT. THE CUSTOMER DID NOT FALL AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634691 HUGO HUGO QUADPOD ULTRA STABLE CANE TIP INP AMG MEDICAL INC. 781-030

    Patients

    Seq Age Sex Outcome Treatment
    1