BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGILON 4/0 BLACK 5X18 T-30/CV-22

    MDR report key: 3110476 · Received April 30, 2013

    Report

    Report Number
    9612501-2013-00041
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SURGEON COMPLETED SUTURING AND PULLED THE THREAD AWAY FROM NEEDLE "BREAKAWAY NEEDLE". THE SURGEON NOTICED THAT THE NEEDLE BROKE IN HALF. THE THREAD DID NOT HAVE ANY NEEDLE ATTACHED TO IT AND THE NEEDLE HOLDER ONLY HAD HALF OF THE NEEDLE. THE SURGICAL SITE WAS SEARCHED AND SURROUNDING PATIENT AREAS WERE ALSO THOROUGHLY SEARCHED FOR THE OTHER HALF OF THE NEEDLE. IT WAS NOT FOUND. SKULL X-RAY WAS DONE AND REVEALED NO FOREIGN BODY ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186336 SURGILON 4/0 BLACK 5X18 T-30/CV-22 SURGILON GAR COVIDIEN D2D0309X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other