BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 1851158 · Received September 29, 2010

    Report

    Report Number
    1313525-2010-00017
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    June 18, 2009
    Report Date
    September 1, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER INFORMATION IS NOT KNOWN. NO MEDICAL RECORDS HAVE BEEN RECEIVED AND THE CAUSE OF THE EVENT IS UNKNOWN. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) THAT A PATIENT REPORTED VISITING A HOSPITAL ,WHILE ON VACATION IN (B)(6) AND WAS DIAGNOSED WITH AN 'AGGRESSIVE BACTERIAL INFECTION IN RIGHT EYE". PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT FOLLOWED UP AT (B)(6) HOSPITAL IN (B)(6) AND WAS ADMITTED FOR A CORNEAL ULCER FOR TWO DAYS, TREATED WITH ANTIBIOTICS. PATIENT REPORTS HAVING A CORNEAL TRANSPLANT ON (B)(6) 2010, AT (B)(6) HOSPITAL IN (B)(6) AND CLAIMS THE HOSPITAL WAS UNABLE TO DETERMINE "WHICH BACTERIA CAUSED THE FUSARIUM KERATITIS". PATIENT RECOVERED, BUT IS FOLLOWING UP WITH DOCTOR EVERY FOUR WEEKS SINCE CORNEAL TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU (UNKNOWN TYPE) NONE LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O| R PUREVISION (BALAFILCON A) CONTACT LENSES