BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 997880 · Received January 14, 2008

    Report

    Report Number
    1313525-2008-00007
    Event Type
    Injury
    Date Received
    January 14, 2008
    Date of Event
    May 19, 2005
    Report Date
    January 16, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH REDNESS, DISCOMFORT, AND LIGHT SENSITIVITY. SHE HAD SELF TREATED HERSELF WITH TOBRAMYCIN. SLIT LAMP EXAMINATION REVEALED SMALL WHITISH INFILTRATES OD AND MULTIPLE SMALL WHITISH INFILTRATE OS. PT WAS DIAGNOSED WITH CORNEAL ULCERS OS>OD AND TREATED WITH ZYMAR. PT WAS SEEN AGAIN TWO DAYS LATER. SLE SHOWED CONJUNCTIVA INJECTED 1 +, OD AND QUIET OS. CORNEA PRESENTED WITH PARA CENTRAL ULCER WITH SUPERFICIAL INFILTRATE OD, AND 2 SMALL INFILTRATES, OS. ANTERIOR CHAMBER, DEEP WITH 2+CELL/FLARE, OD, AND DEEP AND QUIET, OS. TOBRADEX WAS ADDED TO THE TREATMENT REGIME. PT WAS DIAGNOSED WITH CORNEAL ULCER OD AND IRITIS, OD. CONTACT LENSES CULTURED POSITIVE FOR FUSARIUM SPECIES. NO INFO AVAILABLE ON CORNEAL CULTURES. DIAGNOSIS WAS REVISED TO CORNEAL ULCER, OU AND ANTERIOR UVEITIS, OD AND WAS TREATED WITH ZYMAR, POLYTRIM, NATAMYCIN AND LOTEMAX. AT FOLLOW-UP APPROX THREE MONTHS LATER, PT PRESENTED WITH OPACITIES IN THE RIGHT EYE AND SUPERFICIAL PUNCTATE KERATITIS IN BOTH EYES. RECORDS INDICATE THAT THE PT RECOVERED WITH A FAINT CENTRAL STROMAL SCAR, OD AND CLEAR OS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK NONE LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R