BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3011082 · Received March 14, 2013

    Report

    Report Number
    1045834-2013-00674
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT 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 IN WHICH THE DEVICE WAS RETURNED IN A BOX WITH ITEMS THAT WERE BEING RETURNED ON A SALES SUPPORT AUTHORIZATION NUMBER. THE REPORTER SATES THAT ONE OF THE DEVICES THAT WAS RETURNED HAD A COMPLAINT, BUT THE REPORTER WAS UNAWARE OF WHICH DEVICE HAD THE MALFUNCTION. IT WAS UNK TO THE REPORTER WHETHER OR NOT THERE WERE ANY INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108551 EMAX 2 MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1