BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC SELENIA DIMENSIONS

    MDR report key: 6185566 · Received December 14, 2016

    Report

    Report Number
    MW5066761
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    August 25, 2016
    Report Date
    December 14, 2016
    Manufacturer
    HOLOGIC
    Product Code
    OTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD A MAMMOGRAM PERFORMED ON (B)(6) 2016 USING A HOLOGIC SELENIA DIMENSIONS 3D MAMMOGRAPHY MACHINE. THE PT HAD BILATERAL SILICONE BREAST IMPLANTS. TWO RADIOLOGISTS READ THE IMAGES AND INTERPRETED BILATERAL LEAKING IMPLANTS. THE PT REPORTEDLY WENT TO HER SURGEON WHO EXPLANTED THE IMPLANTS BASED ON THIS READING. UPON EXPLANTATION, IT IS REPORTED THE IMPLANTS WERE NOT LEAKING. THE HOLOGIC'S COMPANY WAS CONTACTED AND ASSESSED THE MACHINE AND REPORTED IT WAS WORKING AND THIS WAS AN ARTIFACT. HOWEVER, NONE OF THE RADIOLOGISTS HAD SEEN AN ARTIFACT SUCH AS THIS. THEN TWO WEEKS AFTER ANOTHER PT, WITHOUT IMPLANTS HAD SIMILAR ARTIFACT VISUALIZED FROM A DIFFERENT 3D MACHINE. HOLOGIC AGAIN ASSESSED THE MACHINES AND PERFORMED ROUTINE MAINTENANCE. THE COMPANY HAS TOLD US IT WAS "NORMAL AND EXPECTED BECAUSE IT IS OUT OF THE AREA OF FOCUS." WE ARE NOT SATISFIED WITH THIS RESPONSE AND ARE PURSUING FURTHER INVESTIGATION. IF THE RADIOLOGISTS SEE THIS "ARTIFACT" THEY ARE NOW REQUESTING MRI OF THE BREAST OR OTHER FURTHER STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823726 HOLOGIC SELENIA DIMENSIONS HOLOGIC SELENIA DIMENSIONS OTE HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR