BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 12335979 · Received August 18, 2021

    Report

    Report Number
    3009809074-2021-00006
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 16, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH PROKERA SLIM ON (B)(6) 2021. PATIENT INDICATION WAS SUPERFICIAL KERATITIS. THE PATIENT HAD THE PROKERA REMOVED THE DAY AFTER INSERTION DUE TO DISCOMFORT. UPON REMOVAL, THE TREATING PHYSICIAN NOTED SIGNS OF A POSSIBLE INFECTION. THE PATIENT'S EYE WAS NOT CULTURED AS A RESULT. THE PATIENT WAS PRESCRIBED ANTIBIOTIC OPHTHALMIC DROPS. THE INFECTION HAD RESOLVED BY THE TIME OF THEIR FOLLOW-UP APPOINTMENT WITH THE TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232426 PROKERA PROKERA SLIM NQB N/A BTR198806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention