BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAWKINS III BLN

    MDR report key: 1467911 · Received July 2, 2009

    Report

    Report Number
    1036710-2009-00010
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 28, 2009
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    GDM
    PMA / PMN Number
    K870523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES HAVE NOT BEEN RETURNED BY THE CUSTOMER TO CONFIRM THE DEFECT REPORTED. THIS CONDITION IS CAUSED WHEN A NEEDLE IS NOT FULLY IN THE POUCH AND RUNS THROUGH THE SEALER BARS. THE MISALIGNED BARS THEN REDUCE THE PRESSURE PLACED ON THE POUCH. THIS CONDITION HAS BEEN PREVENTED BY REFURBISHING THE MACHINES. THE DEFECT WAS ADDRESSED WITH THE PACKAGING DEPT BY THE PLANT MGR AND THE PRODUCTION MGR.

    Description of Event or Problem · 1

    REPORT RECEIVED: THE POUCH WAS OPEN INSIDE OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAWKINS III BLN HAWKINS III BLN GDM ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES, INC. 253100 82741Q36

    Patients

    Seq Age Sex Outcome Treatment
    1