BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-0 VICRYL SH

    MDR report key: 1781960 · Received July 29, 2010

    Report

    Report Number
    1781960
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SUTURE TIP UNEXPECTEDLY DETACHED FROM THE NEEDLE IN THE PATIENT. RETRIEVED WITH NO APPARENT HARM OR DISTRESS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-0 VICRYL SH SUTURE GAM ETHICON, INC. 3-0 VICRYL SH CD2650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR