BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOT

    MDR report key: 2979880 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00036
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    November 4, 2010
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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

    I HAVE NUMEROUS MARKING PADS THAT THE PAD IS COMING OFF ONTO THE INSTRUMENT WHEN USING TO MARK TORIC PTS. IT COMES OFF IN CLUMPS ON THE MARKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78837 VISCOT CORNEAL MARKING PAD FZZ ASPEN SURGICAL PRODUCTS, INC. 2012-03-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Other