BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD CRANITOME, BLACK MAX

    MDR report key: 3042707 · Received April 2, 2013

    Report

    Report Number
    1045834-2013-01167
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    December 2, 2011
    Report Date
    January 24, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS 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 (B)(6) STATING THE DEVICE WAS "HEATING." THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134833 STANDARD CRANITOME, BLACK MAX GFF THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1