BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENTUBE

    MDR report key: 3687367 · Received March 11, 2014

    Report

    Report Number
    3687367
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 3, 2014
    Report Date
    February 28, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE STENTUBE LACRIMAL INTUBATION SET-LARGE DIAMETER, ONE OF THE TUBES BROKE AWAY FROM THE INSERTER. THREE TUBES WERE ON THE FIELD-TWO WERE USED; THE DEFECTIVE ONE REMOVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145642 STENTUBE LACRIMAL STENTS AND INTUBATION SETS HNL QUEST MEDICAL, INC. UNK 0448683S01 OR 0440663A09

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NOT APPLICABLE.