BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS SURGICAL SUTURE

    MDR report key: 1022046 · Received March 31, 2008

    Report

    Report Number
    MW5006059
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ETHICON
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, SURGEON IDENTIFIED THAT THE SUTURE-NEEDLE IN USE WAS MISSING THE TIP OF THE NEEDLE. SURGEON CORD SCRUB NURSE UNABLE TO LOCATE NEEDLE TIP. THE IDENTIFICATION OF THE SUTURE + NEEDLE USED 2-0 VICRYL (UNDYED) PLUS SH TAPER NEEDLE VCP 417.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL PLUS SURGICAL SUTURE VICRYL 2-0 ON SH TAPTER NEEDLE GAM ETHICON 2-0 VICRYL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR