BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONODEK SUTURE BN

    MDR report key: 2260060 · Received August 26, 2011

    Report

    Report Number
    1018233-2011-00238
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    TELEFLEX INC.
    Product Code
    NEW
    PMA / PMN Number
    K030212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BARD HAS ATTEMPTED TO OBTAIN ADDITIONAL INFO WITHOUT ANY SUCCESS. THE ACTUAL SAMPLE REMAINS IN THE PT. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE MFG PROCESS WAS REVIEWED AND FOUND THAT THE SUTURE IS RECEIVED FROM AN EXTERNAL SUPPLIER WHO CERTIFIES THAT THE PRODUCT MET ALL SPECIFICATION REQUIREMENTS. WE WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE BULLET TIP BROKE OFF DURING THE PROCEDURE. THE SURGEON WAS PERFORMING A CYSTOCELE ANTERIOR REPAIR WITH VAULT SUSPENSION. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONODEK SUTURE BN NEW TELEFLEX INC. NA 020C1103012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CAPIO DEVICE