BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ BENGER PROBE HOOK

    MDR report key: 3744290 · Received January 30, 2014

    Report

    Report Number
    1920664-2014-00009
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WHILE THE DOCTOR WAS PERFORMING A TEAR DUCT PROCEDURE THE PROBE BROKE INSIDE THE PATIENT'S NOSE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66363 STORZ BENGER PROBE HOOK HAND HELD SURGICAL INSTRUMENT HNL BAUSCH & LOMB, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1