BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACELL

    MDR report key: 2960416 · Received February 6, 2013

    Report

    Report Number
    1836161-2013-00007
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    July 14, 2010
    Report Date
    February 5, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    HOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD- PRODUCT WAS RETURNED AND VISUAL INSPECTION CONFIRMED COMPLAINT. RESULTS- OPERATIONAL PROBLEM. THE DYE USED TO CUT THE PVA SPEARS DID NOT CUT AS INTENDED, RESULTING IN SPONGE PARTICULATE FROM THE DEVICE. CONCLUSIONS: MAINTENANCE DEFICIENCY, ALL DYES WERE SENT OUT TO BE SHARPENED AND A PM WAS PUT INTO PLACE.

    Description of Event or Problem · 1

    CUSTOMER WAS FINDING THAT THE SPONGES WERE LEAVING FRAGMENTS WHEN WIPED ON THE SURFACE OF THE CORNEA. THIS WAS HAPPENING IN THE WET EXPANDED FORM AND THE DRY FORM. WHEN USED ON THE STROMAL BED UNDER A LASIK, FLAP PARTICLES WERE LEFT IN THE INTERFACE OF SEVERAL PATIENTS. WHEN USED ON THE STROMAL BED OF PRK, MANY FRAGMENTS WERE LEFT AND COULD NOT BE REMOVED WITH IRRIGATION WITH BSS. SEVERAL PATIENTS HAVE THOSE SPONGE FRAGMENTS NOW INCORPORATED INTO THEIR REGENERATED EPITHELIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49489 ULTRACELL PVA EYE SPEAR HOZ ASPEN SURGICAL PRODUCTS, INC. 2013-03-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other