BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDMAN APPLANATION TONOMETER

    MDR report key: 563514 · Received November 10, 2004

    Report

    Report Number
    MW1034067
    Event Type
    Injury
    Date Received
    November 10, 2004
    Date of Event
    June 1, 2004
    Report Date
    November 10, 2004
    Manufacturer
    UNK
    Product Code
    HKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN WAS DOING A GLAUCOMA TEST ON PT IN CLINIC. THE PT EXPERIENCED PAIN IN THE RT EYE DUE TO THE DEVICE. THE PT HAS HAD IMPAIRED VISION AFTER THE EVENT. THE RT EYE HURTS. THE EYE DR AND TECHNICIAN DENIED THAT THERE WAS ANY PROBLEM WITH THE DEVICE OR THE OPERATION OF THE DEVICE. PT VISITED ANOTHER PHYSICIAN, WHO CERTIFIED THAT THE CORNEA WAS DAMAGED DUE TO THE DEVICE. THIS PHYSICIAN HAS RECOMMENDED CORNEAL TRANSPLANT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDMAN APPLANATION TONOMETER USED TO MEASURE GLAUCOMA HKX UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability