BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO MEMORY STAPLE

    MDR report key: 2796352 · Received October 15, 2012

    Report

    Report Number
    1833506-2012-00003
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BIOPRO, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EIGHT STAPLES FROM SAME LOT WERE TESTED AND ALL STAPLES FUNCTIONED AS INTENDED FOR USE.

    Description of Event or Problem · 1

    STAPLE WAS REMOVED AND REPLACED BECAUSE THE DOCTOR FELT THAT IT DID NOT COMPRESS PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO MEMORY STAPLE STAPLE GDW BIOPRO, INC. 17631 111850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention