BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVALON

    MDR report key: 365526 · Received December 6, 2001

    Report

    Report Number
    1928508-2001-00003
    Event Type
    Injury
    Date Received
    December 6, 2001
    Report Date
    November 5, 2001
    Manufacturer
    M-PACT
    Product Code
    HOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVERAL CASES OF DLK (DIFFUSE LAMELLAR KERATITIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55054 IVALON PVA SURGICAL SPEAR HOZ M-PACT Q604233 NR

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention SOAPS, MARKING PEN AND PAD. GLOVES, CLINICAL| ANTIBIOTICS, ARTIFICIAL TEAR, INSTRUMENT CLEANING| NUMEROUS AUTOCLAEVABLE REUSEABLES, MIRCOKERATOME,| AND BLADE, BALANCED SALT SOLUTION, ANESTHETIC,| AUTOCLAVE, FLAP MANIPULATORS.