BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G

    MDR report key: 4060367 · Received August 8, 2014

    Report

    Report Number
    1920664-2014-00148
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT 2 OF 4, SEE 1920664-2014-00147, 0014, 00150.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE IRRIGATION TIP HAD PARTICULATE FLAKING OFF IN THE PT'S EYE. THE FLAKES WERE REMOVED WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473276 STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G SIMCO DOUBLE BARRELED 23G I/A UNIT HNR BAUSCH & LOMB, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1