BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRON

    MDR report key: 144668 · Received January 13, 1998

    Report

    Report Number
    MW1012817
    Event Type
    Malfunction
    Date Received
    January 13, 1998
    Date of Event
    January 7, 1998
    Report Date
    January 7, 1998
    Manufacturer
    KATENA PRODUCTS, INC.
    Product Code
    HNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECT IN THE CORNEAL PUNCH CAUSED THE CORNEA TRANSPLANT TISSUE TO BE CUT INACCURATELY AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRON CORNEAL PUNCH HNJ KATENA PRODUCTS, INC. K20-2079 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other