BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 2896731 · Received December 28, 2012

    Report

    Report Number
    1045834-2012-00182
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND NO HOLE WAS OBSERVED. THE EVENT COULD NOT BE DUPLICATED THEREFORE THE EVENT WAS NOT CONFIRMED. IF ADD¿L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THERE WAS A ¿HOLE IN THE HOSE.¿ THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES REPORTED. THERE WAS NO ADD¿L INFO PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1