BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORIA PUNCH D8.00 MM

    MDR report key: 9165941 · Received October 8, 2019

    Report

    Report Number
    9165941
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    May 10, 2019
    Report Date
    September 12, 2019
    Manufacturer
    MORIA INC.
    Product Code
    HNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER SURGEON CUT THE DONOR TISSUE, IT WAS NOTED THAT TISSUE WAS NOT COMPLETELY CUT MAKING TISSUE NOT USABLE FOR SURGERY. WHILE INSPECTING THE PUNCH, A DEFECT WAS NOTED ON THE BLADE. THE SECOND STAGE OF SURGERY WAS DELAYED DUE TO NEED FOR NEW TISSUE FROM EYE BANK. THE EYE INCISION SUTURED CLOSED UNTIL NEW TISSUE ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962068 MORIA PUNCH D8.00 MM PUNCH, CORNEO-SCLERAL HNJ MORIA INC. D8.00 MM 1190209

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA