BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE

    MDR report key: 2190560 · Received November 2, 2007

    Report

    Report Number
    3004365956-2007-00053
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    September 24, 2007
    Report Date
    October 5, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WILL MONITOR THIS ISSUE THROUGH TRENDING. THE DEVICE WAS NOT RETURNED AND IS UNAVAILABLE FOR EVALUATION. NO RESULTS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A PROCEDURE, A PROCEDURE ON ONE OF THE BULLETS BECAME DETACHED. PHYSICIAN ATTEMPTED TO REMOVE THE BULLET BUT WAS UNSUCCESSFUL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE OUTCOME TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE SUTURE GAW TELEFLEX MEDICAL 114623

    Patients

    Seq Age Sex Outcome Treatment
    1