BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTYC SURGICAL PRODUCTS

    MDR report key: 1280735 · Received January 5, 2009

    Report

    Report Number
    MW5009538
    Event Type
    Injury
    Date Received
    January 5, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VALVE ON PRODUCT MALFUNCTIONED, SO DEVICE WAS UNABLE TO BE INFLATED OR DEFLATED. NEW DEVICE OPENED AND USED. DATES OF USE: 2009. DIAGNOSIS: BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTYC SURGICAL PRODUCTS MAMMOSITE CAVITY EVALUATION DEVICE JAQ CYTYC SURGICAL PRODUCTS 9031 08S04MC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention