BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITLENG PROBE S1-1460U

    MDR report key: 2484825 · Received March 5, 2012

    Report

    Report Number
    MW5024556
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 5, 2012
    Manufacturer
    FCI OPHTHALMICS
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTRODUCER BROKE DURING PROCEDURE. WILL REQUIRE ADD'L SURGERY TO RETRIEVE. PROCEDURE: PROBLEMS WITH BALLOON DACRYOPLASTY LEFT EYE WITH POSSIBLE RITLENG TUBE PLACEMENT LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITLENG PROBE S1-1460U INTRODUCER OKS FCI OPHTHALMICS S1 1460U

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention