BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAL SHIELDS

    MDR report key: 5355993 · Received January 8, 2016

    Report

    Report Number
    2428235-2016-00001
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 11, 2015
    Report Date
    January 8, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    MOE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS UNRESPONSIVE AS TO CONDITION POST TREATMENT AND NO PICTURES HAVE BEEN PROVIDED. EVALUATION OF CORNEAL EYE SHIELD HAS NOT BEEN ABLE TO BE PERFORMED. A MEDICAL DEVICE REPORT IS BEING FILED AS AN UNCONFIRMED BUT POTENTIALLY SERIOUS INJURY MAY HAVE OCCURRED. DEVICE WAS UNABLE TO BE EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE IS A DEFAULT ON THE EDGE OF THE CORNEAL EYE SHIELD WHICH HAD CAUSED AN OCULAR LESION WHEN THE EYE SHIELD WAS USED. THIS RESULTED IN BLEEDING UNDER THE CONJUNCTIVA AND PATIENT WAS GIVEN COLLYRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14706 CORNEAL SHIELDS OPTHALMIC EYE SHIELD H71 MOE CYNOSURE, INC. DBA ELLMAN H71 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other