BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000153-2016-00816

    MDR report key: 6079339 · Received November 4, 2016

    Report

    Report Number
    6000153-2016-00816
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 10, 2016
    Report Date
    January 10, 2017
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE TUNNELING TOOL REVEALED THAT BOTH ENDS OF THE STRAW WERE DAMAGED. DUE TO THE DAMAGE TO THE STRAW, ONLY THE THICKNESS COULD BE CHECKED. THE THICKNESS MEASURED WITHIN SPECIFICATION ON BOTH ENDS OF THE STRAW.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING AN ADVANCED TRIAL PROCEDURE THE PLASTIC STRAW THAT GOES OVER THE TUNNELER WAS "CRINKLING," THEY "TRIED TO REVERSE IT AND THE SAME THING HAPPENED." A DIFFERENT STRAW WAS USED AND THE NEW STRAW DID NOT CRINKLE AND WORKED JUST FINE. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATED THAT THE STRAW CRINKLED WHEN IT WAS INTRODUCED INTO THE SUBCUTANEOUS LATER OF THE SKIN. THE SURGEON RE-LOADED THE STRAW TO REINSERT THE STRAW, AND THAT SIDE CRINKLED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731616 MHY NEURO - VILLALBA NEU_TUNNELINGTOOL

    Patients

    Seq Age Sex Outcome Treatment
    1