BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2901520 · Received January 3, 2013

    Report

    Report Number
    1045834-2013-00029
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 7, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. 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 PRODUCT "RUNS ROUGH". THE DEVICE WAS USED IN A EAR SURGERY. THERE WERE NO USER OR PATIENT INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191 EMAX 2 PLUS MOTOR HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1