BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINESSE

    MDR report key: 3131161 · Received May 22, 2013

    Report

    Report Number
    MW5030282
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 10, 2012
    Report Date
    May 22, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE BIOPSY DEVICE WOULD NOT RELEASE FROM THE PT. THE PROBE HAD TO BE REMOVED WITH FORCEFUL PULLING. -(B)(4)-TS NOTE: THE COMPLAINT WAS SUBMITTED AS A CATEGORY 1 AND WAS RECLASSIFIED BY THE (B)(4) -MEDICAL ADVISORS- TO A CATEGORY 2. THERE ARE NO OTHER ADVERSE REPORTS AT (B)(4) OR THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227369 FINESSE ULTRA BIOPSY DRIVER KNW BARD PERIPHERAL VASCULAR, INC F01BLU 90000004

    Patients

    Seq Age Sex Outcome Treatment
    1