BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CORNEO-GAGE II

    MDR report key: 16700 · Received October 10, 1994

    Report

    Report Number
    MW1003643
    Event Type
    Malfunction
    Date Received
    October 10, 1994
    Date of Event
    August 11, 1994
    Report Date
    September 22, 1994
    Manufacturer
    SONOGAGE, INC.
    Product Code
    HJB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RADIAL KERATOTOMY PACHOMETER WAS MALFUNCTIONING WHEN PURCHASED BY RPTR'S FACILITY. THE READINGS WERE UNRELIABLE. IT WAS RETURNED TO THE MFR TO BE REPAIRED AND ARRIVED STILL BROKEN. IT WAS USED AND RETURNED AGAIN TO BE REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM CORNEO-GAGE II PACHOMETER HJB SONOGAGE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other