BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2 SLIT SCREW-IN TIP KNIFE

    MDR report key: 40832 · Received September 30, 1996

    Report

    Report Number
    1644019-1996-00033
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    August 29, 1996
    Report Date
    August 29, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HNN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTS DR HAS EXPERIENCED DIFFICULTIES WITH SURGICAL KNIFE. THE INCISIONS ARE LARGER WITH FLUID LEAKAGE. AN IRIS PROLAPSED AND REQUIRES SUTURES. FOLLOW-UP WITH PHYSICIAN CONFIRMS THIS REPORT. HE INDICATES THAT HE EXPERIENCED DIFFICULTIES ON ONE DAY WITH THE "NEW KNIFE. HE REPORTS WOUND LEAKAGE AND CHAMBER COLLAPSE. THE PROLAPSED IRIS WAS REPAIRED AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.2 SLIT SCREW-IN TIP KNIFE KNIFE HNN ALCON LABORATORIES, INC. NA M877370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention