BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM DK-LK BON+1 C7 IN 7-4" 2L

    MDR report key: 1812411 · Received August 12, 2010

    Report

    Report Number
    3004365956-2010-00194
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PRIOR TO THE PRODUCT BEING USED ON A PATIENT, THE SUTURE DETACHED EASILY FROM THE NEEDLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEM DK-LK BON+1 C7 IN 7-4" 2L SUTURE GAT TELEFLEX MEDICAL NA 3213691

    Patients

    Seq Age Sex Outcome Treatment
    1