BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN SUTURE

    MDR report key: 664170 · Received January 13, 2006

    Report

    Report Number
    2210968-2006-00058
    Event Type
    Other
    Date Received
    January 13, 2006
    Report Date
    December 19, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BECOMING AWARE OF A NEEDLE TIP THAT BROKE DURING SKIN CLOSURE. CUSTOMER ADVISED THAT ATTENDING ATTEMPTED TO TAKE A LARGE BITE OF TISSUE AND PUSHED THE NEEDLE TO EXPOSE THE TIP. TIP BROKE UPON GRASPING WITH NEEDLE HOLDERS. IT IS ASSUMED THAT THE NEEDLE TIP IS RETAINED WITHIN THE PATIENT TISSUE. NO ADVERSE EVENT IS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE SUTURE GAO ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN