BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 FOOT CONTROL

    MDR report key: 3080927 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02039
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICE MET MANUFACTURING SPECIFICATIONS. NO PROBLEM WAS FOUND. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE "WAS INTERMITTENTLY STOPPING". THE EVENT OCCURRED DURING SURGERY. NO INJURIES OR INTERVENTION WAS REPORTED. THERE IS NOT ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176957 EMAX 2 FOOT CONTROL HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1