BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROKERA OPHTHALMIC BIOLOGICAL TISSUE

    MDR report key: 9695001 · Received February 10, 2020

    Report

    Report Number
    MW5092924
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 6, 2020
    Manufacturer
    TISSUETECH, INC.
    Product Code
    NQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLUE RUBBER RING DETACHED FROM PROKERA CLEAR IN PT'S EYE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150013 PROKERA OPHTHALMIC BIOLOGICAL TISSUE COMFORMER, OPHTHALMIC BIOLOGIC TISSUE NQB TISSUETECH, INC. 19PKCLR00159

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other