BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20159989 · Received September 5, 2024

    Report

    Report Number
    MW5159271
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 31, 2024
    Manufacturer
    CORNEAT
    Product Code
    QWU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT UNEVENTFUL ROUTINE GLAUCOMA SURGERY WITH A CLEARPATH 350 TUBE SHUNT AND A CORNEAT EVERPATCH SYNTHETIC PATCH GRAFT TO COVER THE TUBE ON (B)(6) 2024. THE HEALING PROCESS WAS ROUTINE, UNTIL (B)(6) 2024 (6 WEEKS AFTER SURGERY), AT WHICH POINT CONJUNCTIVAL DEHISCENCE AND RETRACTION WAS NOTED, AND THE EVERPATCH WAS EXPOSED. THIS EXPOSED AREA CONTINUED TO ENLARGE AND DID NOT RE-EPITHELIALIZE IN THE HEALING PROCESS. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM ON (B)(6) 2024 FOR EXCHANGE OF THE EVERPATCH WITH A CORNEAL HALF-MOON PATCH GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536383 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R