BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171089 · Received September 6, 2024

    Report

    Report Number
    MW5159324
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CORNEAT VISION LTD.
    Product Code
    QWU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT GLAUCOMA TUBE SHUNT IMPLANTATION IN THE RIGHT EYE ON (B)(6) 2024 AND THE CORNEAT EVERPATCH WAS USED TO COVER THE TUBE. AT POW4, THE CONJUNCTIVA WAS NOTED TO HAVE RETRACTED AND THE EVERPATCH WAS EXPOSED. THE PATIENT HAS BEEN OBSERVED WITH NO FURTHER INTERVENTION TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297603 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION LTD. 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other