BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TAPER-CUT SUTURE

    MDR report key: 2052026 · Received February 28, 2011

    Report

    Report Number
    3004365956-2011-00084
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DEVICE MALFUNCTIONED. DURING A URINARY SLING PROCEDURE THE BULLET TIP OF THE CAPIO SUTURE BECAME DETACHED FROM THE SUTURE WHEN THE SURGEON WAS ANCHORING THE SLING FORCING THE SURGEON TO LEAVE THE BULLET TIP INSIDE THE PATIENT. THE CONDITION OF THE PATIENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEK BL MF 0 TAPER-CUT SUTURE CAPIO SUTURE GAW TELEFLEX MEDICAL NA 02D1003285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK