BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE

    MDR report key: 1022662 · Received April 1, 2008

    Report

    Report Number
    3004365956-2008-00008
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 28, 2008
    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 CONTINUE TO MONITOR THIS ISSUE THROUGH TRENDING. THE DEVICE WAS NOT RETURNED. NO RESULTS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR DURING A PROCEDURE, THE CAPIO SUTURE BULLET CAME LOOSE AND DISLODGED IN THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A COMPETITOR'S DEVICE WITH NO ADVERSE OUTCOME TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE SUTURE GAW TELEFLEX MEDICAL 131719

    Patients

    Seq Age Sex Outcome Treatment
    1