BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ BENGER HOOK

    MDR report key: 3954690 · Received July 18, 2014

    Report

    Report Number
    1920664-2014-00138
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY WAS PROLONGED; HOWEVER THE PARTICLE WAS REMOVED WITH NO REPORT OF INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING SURGERY THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S NOSE. THE SURGEON COULD NOT FIND THE TIP; THEREFORE, CALLED IN AN EAR NOSE AND THROAT SURGEON, WHO REMOVED THE TIP OF THE INSTRUMENT. THE SURGERY WAS PROLONGED; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY. THE PATIENT IS STILL UNDER TREATMENT, AND POST-OP INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422136 STORZ BENGER HOOK HNR BAUSCH & LOMB, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention