BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTICARE PLATINUM

    MDR report key: 1221812 · Received November 4, 2008

    Report

    Report Number
    1220984-2008-00003
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 4, 2008
    Manufacturer
    HOLOGIC INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE A HOLOGIC FIELD ENGINEER EVALUATE THIS PARTICULAR TABLETOP. THE CUSTOMER INSISTS THIS PROBLEM WAS CAUSED BY A DESIGN ISSUE WITH THE TABLETOP. THE MULTICARE PLATINUM WAS INSTALLED IN JULY 2008 (TABLETOP WAS REPLACED ON (B)(6)2008). USER TRAINING WAS PROVIDED BY A HOLOGIC APPLICATIONS SPECIALIST PRIOR TO USE ON PTS, HOWEVER, THE HOLOGIC SPECIALIST WAS NOT ALLOWED TO OBSERVE SITE PERSONNEL WHEN PERFORMING THE PROCEDURE ON ACTUAL PATIENTS. OBSERVING THE USER PERFORM THE PROCEDURE ON INITIAL PTS IS PART OF THE NORMAL TRAINING PROCESS. HOLOGIC OFFERED THE CUSTOMER ADDITIONAL TRAINING ON THE USE OF THE MULTICARE PLATINUM AT NO CHARGE TO THE CUSTOMER, THE OFFER WAS ACCEPTED AND THE TRAINING WAS COMPLETED ON (B)(6)2008. NO ADDITIONAL INCIDENCES HAVE BEEN REPORTED SINCE THE ADDITIONAL TRAINING WAS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    HOLOGIC WAS NOTIFIED THAT A PT REPORTED AN INJURY AFTER HAVING BIOPSY PROCEDURES PERFORMED ON A MULTICARE PLATINUM SYSTEM. IT WAS REPORTED THAT THE CUSTOMER COMPLAINED OF A POPPING SOUND AND PAIN UNDER THE BREAST, AFTER A SCOUT IMAGE. THE PT THEN STATED THEY WERE FINE AND DID NOT COMPLAIN FURTHER UNTIL POST-OP FILMS WERE TAKEN ON A MAMMOGRAPHY SYSTEM IN ANOTHER ROOM. ON (B)(6)2008, THE PT REPORTED TO THE SITE THAT THERE WAS TRAUMA TO HER RIBS, BUT NO FRACTURE. THE MULTICARE PLATINUM IS A BIOPSY DEVICE THAT REQUIRES THE PT TO LAY FACE-DOWN WHILE A BREAST IS POSITIONED THROUGH A HOLE IN THE TOP OF THE BIOPSY TABLE. IT SHOULD BE NOTED THAT THE PT IS REPORTED TO BE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICARE PLATINUM PRONE BIOPSY SYSTEM KNW HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other