BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOLENOID

    MDR report key: 23983 · Received July 6, 1995

    Report

    Report Number
    23983
    Event Type
    Other
    Date Received
    July 6, 1995
    Date of Event
    March 8, 1995
    Report Date
    March 27, 1995
    Manufacturer
    ALCON SURGICAL, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUCTION OF I/A REMAINED AFTER THE FOOT PEDAL WAS RELEASED. RESULT WAS POSSIBLE; SUCTION TRAUMA TO CORNEAL ENDOTHELIUM FOLLOW UP SHOWED PT HAD NO COMPLICATIONS FOLLOWING PROCEDURE. ALCO SERVICE REP CAME IN AND CLEANED SOLENID AND CHECKED OPERATION. ON 3/23/95, SAME PROBLEM REOCCURRED; BOTH SOLENID REPLACED THIS TIME. REP WAS CALLED AGAIN TO CHECK MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLENOID SOLENOID HQC ALCON SURGICAL, INC. 10

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other