BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3042367 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01214
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 8, 2012
    Report Date
    April 16, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "HEATING UP". THE DEVICE WAS BEING USED DURING SPINE SURGERY. NO PATIENT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136403 BLACKMAX-NEURO HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1