BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATEC PEARL

    MDR report key: 14949612 · Received July 7, 2022

    Report

    Report Number
    1222780-2022-00177
    Event Type
    Injury
    Date Received
    July 7, 2022
    Report Date
    July 7, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ATEC PROCEDURE THE PHYSICIAN WAS NOT ABLE TO OBTAIN ADEQUATE SAMPLES. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967907 ATEC PEARL INSTRUMENT, BIOPSY KNW ATEC PEARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female