BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 12335978 · Received August 18, 2021

    Report

    Report Number
    3009809074-2021-00007
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 19, 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 NEXT DAY DUE TO PAIN/DISCOMFORT. UPON REMOVING THE DEVICE, 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
    1233845 PROKERA PROKERA SLIM NQB N/A BTR198806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention