BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3080990 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02023
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE HAS "A HOLE IN THE HOSE." THE REPORTER COULD NOT CLARIFY IF THE DEVICE WAS USED IN SURGERY. IT WAS UNK TO THE REPORTER IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176965 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1