BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTISSUE

    MDR report key: 11412883 · Received March 4, 2021

    Report

    Report Number
    3009809074-2021-00002
    Event Type
    Injury
    Date Received
    March 4, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE CONTACT INFORMATION, OR DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED, THE SOURCE OF THE REPORT CANNOT BE TRACED AND ADDITIONAL INFORMATION CANNOT BE GATHERED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDWATCH MW5098710 FOR PROKERA WAS RECEIVED BY TISSUE TECH, INC. ON 02/09/2021. THE REPORT INDICATED THAT AN ADVERSE EVENT OCCURRED AND THE EVENT OUTCOME WAS "OTHER SERIOUS (IMPORTANT MEDICAL EVENT)". THE DESCRIPTION OF THE EVENT STATED, "LACK OF EFFICACY". NO OTHER DETAILS REGARDING THE ADVERSE EVENT WERE REPORTED. THE REPORTER DID NOT PROVIDE ANY INFORMATION REGARDING THE FACILITY FILING THE REPORT OTHER THAN IT WAS A MEDICAL PROFESSIONAL. TTI HAS NOT RECEIVED ANY COMPLAINTS REGARDING PROKERA WITH THE SAME/SIMILAR DESCRIPTION. SINCE CONTACT INFORMATION, OR DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED, THE SOURCE OF THE REPORT CANNOT BE TRACED AND ADDITIONAL INFORMATION CANNOT BE GATHERED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310842 BIOTISSUE PROKERA NQB

    Patients

    Seq Age Sex Outcome Treatment
    1