BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 12475959 · Received September 15, 2021

    Report

    Report Number
    3009809074-2021-00009
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 15, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED WITH PROKERA SLIM ON (B)(6) 2021. THREE DAYS AFTER INSERTION THE PATIENT PRESENTED WITH AN INFECTION. THE PATIENT EXPERIENCED REDNESS, SWELLING, AND PAIN. THE DEVICE WAS REMOVED AND THE PATIENT WAS SUCCESSFULLY TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. THE TREATING PHYSICIAN INDICATED THE ONLY ABNORMALITY OBSERVED WITH THE DEVICE IS THAT THE STORAGE SOLUTION APPEARED MILKY WHITE COMPARED TO OTHER PROKERAS. THE PHYSICIAN DID NOT CULTURE THE SOLUTION OR THE PATIENT'S EYE AND THE UNIT WAS NOT RETURNED TO TTI FOR INSPECTION. THE MANUFACTURING BATCH RECORD FOR THE PKS LOT WAS REVIEWED AND NO NONCONFORMITIES IDENTIFIED. FINAL PRODUCT MICROBIOLOGY TESTING FOR THE PROKERA LOT INDICATED NO GROWTH. AT THE TIME OF REPORT, ALL OTHER UNITS FROM THE LOT HAD BEEN DISTRIBUTED AND NO OTHER COMPLAINTS RECEIVED. SEVERAL UNITS FROM A DIFFERENT PROKERA LOT REMAINED IN-HOUSE THAT WERE MANUFACTURED THE SAME DAY, WITH THE SAME LOT NUMBER OF STORAGE SOLUTION. THOSE 12 UNITS THAT REMAINED IN INVENTORY WERE CONFIRMED TO HAVE CLEAR STOARAGE SOLUTION. EM DATA COLLECTED IN THE CLEAN ROOM BEFORE AND AFTER THE MANUFACTURE OF THE PROKERA LOT WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371453 PROKERA PROKERA SLIM NQB N/A BTR211645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention