BEUDAMED
    FDA Adverse Event Other Summary report: N

    3F STONE BASKET

    MDR report key: 1141353 · Received August 28, 2008

    Report

    Report Number
    2027111-2008-00038
    Event Type
    Other
    Date Received
    August 28, 2008
    Report Date
    August 25, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RETURNED FROM THE HOSPITAL FOR EVALUATION. UPON EVALUATION OF THE INCIDENT DEVICE, WE WILL PROVIDE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    "WHEN THE SURGEON PICKS UP THE STONE AND BEGINS THE RETRACTOR, A LOOSENING OCCURS OF THE GUIDE AT THE BASE OF THE HANDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3F STONE BASKET STONE BASKET FFL APPLIED MEDICAL RESOURCES B9002 1048003

    Patients

    Seq Age Sex Outcome Treatment
    1