BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD QUICK LOAD SUTURE

    MDR report key: 1623576 · Received March 2, 2010

    Report

    Report Number
    MW5014992
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 23, 2010
    Manufacturer
    LSI SOLUTIONS
    Product Code
    GAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE CASE, THE FERREL (BULLET) WAS NOTED TO BE MISSING FROM THE CAPIO SUTURING DEVICE. THEREFORE, AN XRAY WAS NEEDED. THE CAPIO DEVICE CAUSING AN ISSUE WITH THE FERRELS COMING OFF THE SUTURE AND RESULTING IN AN XRAY FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RD QUICK LOAD SUTURE RD QUICK LOAD SUTURE GAK LSI SOLUTIONS 021030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR