BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX - NEURO

    MDR report key: 3080884 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02038
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Report Date
    January 3, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND COMPLAINT OF "HOSE DAMAGE" WAS NOT CONFIRMED. THE DEVICE MET MANUFACTURING SPECIFICATIONS. NO PROBLEM FOUND. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING "HOSE DAMAGE". THE EVENT DID NOT OCCUR DURING SURGERY. THE DATE OF OCCURRENCE IS UNK. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176041 BLACKMAX - NEURO HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1