BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL

    MDR report key: 3012654 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00033
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    September 20, 2010
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.

    Description of Event or Problem · 1

    THE INK PAD DISINTEGRATES AND THEREFORE, PARTICLES ARE TRANSFERRED FROM THE MARKER TO THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78762 ASPEN SURGICAL CORNEAL MARKING PAD FZZ ASPEN SURGICAL PRODUCTS, INC. 2010-10-07

    Patients

    Seq Age Sex Outcome Treatment
    1