BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM

    MDR report key: 1376467 · Received May 4, 2009

    Report

    Report Number
    2027111-2009-00032
    Event Type
    Other
    Date Received
    May 4, 2009
    Date of Event
    April 6, 2009
    Report Date
    April 9, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED HOSPITAL, AND ARE AWAITING A REPLY TO DETERMINE IF PRODUCT IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    "END OF EDWARDS CLIP BROKE OFF IN TWO SMALL PIECES, NOT SURE IF WAS IN CUSTOM-PACK OR OPENED SEPARATELY. FOUND ALL MISSING BROKEN PIECES. BROKEN CLIP GIVEN TO CHARGE NURSE IN." IT WAS CONFIRMED THROUGH CUSTOMER SERVICE THAT THE DEVICE BROKE INSIDE THE PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention