BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2901506 · Received January 3, 2013

    Report

    Report Number
    1045834-2013-00028
    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 AN EAR SURGERY. THERE WERE NO USER OR PATIENT INJURIES REPORTED. THE REPORTER STATED THAT THEY DID NOT HAVE ANY FURTHER INFORMATION ON THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182 EMAX 2 PLUS MOTOR HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1