BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENGER PROBE HOOK

    MDR report key: 3638680 · Received February 18, 2014

    Report

    Report Number
    3638680
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 3, 2014
    Report Date
    February 18, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A NEW INSTRUMENT SET WAS BEING USED ON A PROCEDURE. THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT'S NOSE DURING THE PROCEDURE. THE PATIENT'S NOSE WAS SUCTIONED OUT AND THE PIECE OF THE INSTRUMENT WAS FOUND IN THE SUCTION CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102908 BENGER PROBE HOOK PROBE, LACHRYMAL HNL BAUSCH & LOMB, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO