BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20MM SPHERE

    MDR report key: 364205 · Received November 28, 2001

    Report

    Report Number
    364205
    Event Type
    Injury
    Date Received
    November 28, 2001
    Date of Event
    October 19, 2001
    Report Date
    October 22, 2001
    Manufacturer
    STORZ OPTHALMUS
    Product Code
    HPZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2001, PT. UNDERWENT AN ENUCLEATION OF THE LEFT EYE SECONDARY TO NEUROTROPHIC KERATITI'S FOLLOWING RADIATION THERAPY FOR IT MAXILLARY SINUS SQUAMOUS CELL CARCINOMA. PRIOR TO THIS SURGERY PT WAS EXPERIENCING PAIN AND PUS LIKE DRAINAGE. A 20MM BALL IMPLANT WAS INSERTED. SUBSEQUENTLY, PT DEVELOPED CHILLS AND PURULENT DRAINAGE (GRAM-POSITIVE COCCI). HAD PREV. BEEN ON CLINDAMYCIN AFTER THE 1ST SURGERY - WHICH WAS THEN STOPPED. EIGHT DAYS LATER, THE IMPLANT WAS REMOVED DUE TO INFECTION IMPLANT EXTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53624 20MM SPHERE SMALL CONFORMER HPZ STORZ OPTHALMUS * S2297

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization SMALL CONFORMER.