BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM

    MDR report key: 860726 · Received June 4, 2007

    Report

    Report Number
    2027111-2007-00041
    Event Type
    Other
    Date Received
    June 4, 2007
    Date of Event
    May 17, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. IF PRODUCT IS RETURNED, EVAL WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "WHEN SURGEON WENT TO REMOVE SOFT JAW SPRING CLIP FROM PT THE DEVICE BROKE APART AND CAME OUT. PART OF THE PLASTIC FELL INSIDE OF CHEST." PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM SURGICAL SPRING CLIPS DSS APPLIED MEDICAL RESOURCES G-6000 1032401

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other