BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL

    MDR report key: 3766466 · Received March 27, 2014

    Report

    Report Number
    3766466
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE NEEDLE HANDED TO ASSISTANT SURGEON BY SURGICAL TECHNICIAN AND WHEN ASSISTANT ATTEMPTED TO PASS IT THOUGH THE DERMIS HE NOTED IT WOULD NOT PASS. ASSISTANT PHYSICIAN THEN EXAMINED TIP OF SUTURE NEEDLE AND NOTED IT WAS BROKEN. PERI-OPERATIVE MANAGER SPOKE TO ASSISTANT; HE STATED HE BELIEVED THE SUTURE HAD ALREADY BEEN USED TO CLOSE ANOTHER PORTION OF THE SKIN BEFORE THE BROKEN TIP WAS NOTED. BROKEN TIP APPROXIMATELY LESS THAN 1.5 MM. CONFIRMED WITH SURGICAL TECHNICIAN, SUTURE HAD BEEN USED BY PRIMARY SURGEON TO CLOSE INITIAL PORT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180481 MONOCRYL SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON, INC. PS-2 4-0 GPZ362

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR