BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL GUT

    MDR report key: 1970600 · Received September 29, 2010

    Report

    Report Number
    1970600
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SUTURING THE RESIDENT NOTICED THE TIP OF NEEDLE WAS MISSING. ORDERED AN X-RAY AND CALLED BIOMED. THE NEEDLE AND PACKAGE WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL GUT SUTURE, NEEDLE GAL ETHICON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR