BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRACANALYSIS

    MDR report key: 1560588 · Received December 10, 2009

    Report

    Report Number
    MW5013962
    Event Type
    Other
    Date Received
    December 10, 2009
    Date of Event
    September 16, 2009
    Report Date
    December 10, 2009
    Manufacturer
    MYRIAD GENETIC LABORATORIES, INC
    Product Code
    OQS
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS AN UNAFFECTED FEMALE PT. HER SISTER WAS DIAGNOSED WITH BILATERAL BREAST CANCER, AND WAS FOUND TO CARRY A BRCA1 MUTATION. THIS PT'S GYNECOLOGIST REFERRED HER TO AN ONCOLOGIST FOR GENETIC TESTING. SHE HAD LITTLE OR NO PRE-TEST COUNSELING. BRCA TESTING WAS ORDERED, AND THE PT WAS FOUND TO CARRY THE FAMILIAL BRCA1 MUTATION. DURING A DISCUSSION OF THE SURVEILLANCE AND RISK REDUCTION OPTIONS, THE PT REPORTS THAT THE ONCOLOGIST DESCRIBED THE OPTION OF PROPHYLACTIC MASTECTOMY AS "CHOPPING OFF THE BREAST." SHE LEFT THE APPOINTMENT WITH THE ONCOLOGIST FEELING FRIGHTENED AND CONFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRACANALYSIS BRCA1 GENE TESTING OQS MYRIAD GENETIC LABORATORIES, INC
    2 BRACANALYSIS BRCA2 GENE TESTING ODJ MYRIAD GENETIC LABORATORIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR