BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20172096 · Received September 6, 2024

    Report

    Report Number
    MW5159341
    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 TUBE WAS COVERED WITH CORNEAT EVERPATCH. BY POW1 IT WAS NOTED THAT THERE WAS CONJUNCTIVAL RETRACTION WITH EXPOSURE OF THE PATCH. THIS HAS BEEN OBSERVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329915 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION LTD 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other