BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL, SC2100

    MDR report key: 3021051 · Received March 20, 2013

    Report

    Report Number
    1045834-2013-00866
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE MET MANUFACTURING SPECIFICATIONS. THE EVENT COULD NOT BE DUPLICATED THEREFORE THE EVENT WAS NOT CONFIRMED. 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 THAT THE DEVICE "STOPPED WORKING AND MADE A WEIRD NOISE" WHEN USED WITH THE CONSOLE. THE DEVICE WAS USED DURING A TYMPANOMASTOID SURGERY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115645 FOOT CONTROL, SC2100 HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1