BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 12548001 · Received September 29, 2021

    Report

    Report Number
    3009809074-2021-00010
    Event Type
    Injury
    Date Received
    September 29, 2021
    Report Date
    September 29, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN POSTED AN INQUIRY ON DOCMATTER, AN ONLINE COLLABORATION PLATFORM FOR HEALTH PROFESSIONALS, INDICATING THEY HAD A PATIENT CASE THAT PRESENTED WITH 2 SMALL CORNEAL INFILTRATES AFTER PROKERA TREATMENT. THE PHYSICIAN STATED THEY REMOVED THE PROKERA AND TREATED THE PATIENT WITH TOPICAL ANTIBIOTICS. THE PATIENT RECOVERED WELL. THE POST WAS AN INQUIRY AS TO WHETHER OTHER PHYSICIAN'S HAVE HAD A SIMILAR EXPERIENCE WITH PROKERA. TISSUETECH, INC.'S MEDICAL DIRECTOR MADE REPEAT ATTEMPTS TO CONTACT THE TREATING PHYSICIAN TO GATHER ADDITIONAL INFORMATION REGARDING THIS CASE BUT A RESPONSE HAS NOT BEEN RECEIVED. DEVICE IDENTIFYING INFORMATION WAS ALSO REQUESTED FROM THE PHYSICIAN AND HAS NOT BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443339 PROKERA PROKERA SLIM NQB N/A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention