BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE BIOPSY INSTRUMENT

    MDR report key: 1935419 · Received November 11, 2010

    Report

    Report Number
    1036710-2010-00036
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIOPINCE DEVICE WAS RETURNED FOR REVIEW FROM THE DISTRIBUTOR. THE END OF THE BLISTER IS CRACKED A HALF INCH FROM THE END OF THE BLISTER INWARD. THIS OCCURRENCE WOULD BE OBSERVED IF THERE WAS A HARD IMPACT DURING SHIPMENT THAT WOULD CAUSE DAMAGE TO THE BLISTER. THE DAMAGE IS NOTICEABLE BY THE END USER. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EVENT DESC: THE BLISTER IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE BIOPSY INSTRUMENT BIOPINCE KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES, INC. 021422AT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other