BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 556360 · Received September 21, 2004

    Report

    Report Number
    MW1033284
    Event Type
    Injury
    Date Received
    September 21, 2004
    Date of Event
    November 30, 2001
    Report Date
    April 23, 2002
    Manufacturer
    *
    Product Code
    LQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD UNCOMPLICATED RIGHT EVISCERATION WITH HYDROXYAPATITE IMPLANT WRAPPED IN DONOR SCLERA. ONE WEEK P/O DEVELOPED INFECTION (STAPH) AND EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HYDROXYAPATITE OCULAR IMPLANT LQF * * *
    2 * DONOR SCLERA LMO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention