BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENICON SF-P

    MDR report key: 187885 · Received September 17, 1998

    Report

    Report Number
    2950360-1998-00007
    Event Type
    Injury
    Date Received
    September 17, 1998
    Date of Event
    October 17, 1997
    Report Date
    September 11, 1998
    Manufacturer
    MENICON USA
    Product Code
    HPX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS CLEANING THE LENS AND IT BROKE. THE EDGE WAS ROUGH AND THAT CAUSED THE LENS TO BREAK. THE LENS WAS HURTING THE PT AND SHE THOUGHT IT WAS DIRTY. THAT IS WHY SHE WAS CLEANING IT. THE EDGE CONDITION SCRATCHED HER CORNEA. SHE SOUGHT TREATMENT FROM HER DR. HER EYE HEALED WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENICON SF-P RIGID GAS PERMEABLE LENS HPX MENICON USA STANDARD 6P06097

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention