BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC ADIANA

    MDR report key: 2615955 · Received May 29, 2012

    Report

    Report Number
    2615955
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 11, 2012
    Manufacturer
    HOLOGIC
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TIP WAS BENT AND UNABLE TO ADVANCE. EQUIPMENT SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC ADIANA ADIANA TREATMENT KNH HOLOGIC 11G09R-145 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR