BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC 0912-20 HANDPIECES

    MDR report key: 824484 · Received February 1, 2007

    Report

    Report Number
    3003862400-2007-00002
    Event Type
    Other
    Date Received
    February 1, 2007
    Date of Event
    December 18, 2006
    Report Date
    January 25, 2007
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC.
    Product Code
    GDF
    PMA / PMN Number
    k042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED IN REGARDING MIS-LABELED POUCHES OF HANDPIECES. PRODUCT IS PURCHASED 5 HANDPIECES PER CASE. CUSTOMER NOTICED THE CASE LABEL FOR LOT 611018 OF THE ATEC 0912-20 HANDPIECES DID NOT MATCH THE POUCH LABELS. SOME POUCHES WERE LABELED AS 0909-20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC 0912-20 HANDPIECES VACUUM ASSISTED CORE BIOPSY DEVICE GDF SUROS SURGICAL SYSTEMS, INC. ATEC 0912-20 611018

    Patients

    Seq Age Sex Outcome Treatment
    1 *