BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2915658 · Received January 10, 2013

    Report

    Report Number
    1045834-2013-00076
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE HOSE HAS A TEAR/HOLE AND WEAR MARKS WHERE THE MOTOR JOINS THE HANDPIECE. THIS WAS MOST LIKELY DUE TO USAGE WEAR OVER TIME AND HANDLING ISSUES AT THE CUSTOMER SITE. THE EVENT WAS 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 ¿CORD WAS COMING APART FROM WHERE IT GOES INTO THE HANDPIECE.¿ THE PRODUCT WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THE REPORTER LATER VERIFIED THAT IT WAS THE HOSE THAT WAS COMING APART WHERE IT GOES INTO THE HANDPIECE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15518 EMAX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1