BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3060515 · Received April 10, 2013

    Report

    Report Number
    1045834-2013-01466
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    April 10, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY ANSPACH. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THE DEVICE WAS "HEATING." THE DEVICE WAS BEING USED DURING A CRANIOTOMY PROCEDURE. THE DATE OF THE EVENT IS UNK. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150279 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1