BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVICIDE

    MDR report key: 2437302 · Received February 2, 2012

    Report

    Report Number
    1722021-2012-00002
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    METREX RESEARCH CORPORATION
    Product Code
    LRJ
    PMA / PMN Number
    K951123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WORKER SOUGHT MEDICAL ATTENTION WITH THE SCHOOL NURSE. THE NURSE WAS NOT DEFINITIVE AS TO HOW LONG IT TOOK THE WORKER TO REACH HER AFTER THE INCIDENT OCCURRED. THE NURSE FLUSHED THE WORKER'S EYE AT AN EYE WASH STATION. THE WORKER EXPERIENCED SYMPTOMS OF A BURNING, RED, AND SWOLLEN EYE. THE WORKER'S EYE CONDITION DID NOT IMPROVE AFTER REPEATEDLY RINSING THE EYE EVERY HOUR, THROUGHOUT THE DAY. THE NURSE ALSO STATED THAT SHE OBSERVED "WHITE SPOTS" UNDERNEATH THE PATIENT'S EYELID, AND ADVISED THE WORKER TO SEEK MEDICAL ATTENTION. THE WORKER SOUGHT MEDICAL ATTENTION WITH AN OPHTHALMOLOGIST AND WAS DIAGNOSED WITH CHEMICAL BURNS ON THE UNDERSIDE OF HER EYELID BY HER EYELASHES, AS WELL AS ON HER EYEBALL. A VISUAL EXAM WAS PERFORMED AND REVEALED HER SIGHT WAS "FUZZY" AS A RESULT OF THE CHEMICAL BURNS. SHE WAS PRESCRIBED EYE DROPS (TOBRAMYCIN/DEXAMET) AS WELL AS AN EYE OINTMENT, TO WHICH SHE CANNOT RECALL THE NAME. THE DOCTOR CONCLUDED THAT HE BELIEVES THE PATIENT WILL MAKE A FULL RECOVERY AND THAT THE BURN IS ONLY ON THE OUTER LAYER OF THE EYEBALL. TO DATE, THE COMPLAINANT HAS FULLY RECOVERED FROM THE ALLEGED INCIDENT; NO FURTHER TREATMENT OR FOLLOW-UP APPOINTMENTS ARE REQUIRED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT EXCEEDED ITS SHELF LIFE; THEREFORE, NO FURTHER INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A COMPLAINANT REPORTED THAT A CHILD HAD THROWN A BOTTLE OF CAVICIDE AND THE TOP OF THE SPRAY NOZZLE BROKE, RELEASING THE PRODUCT. THE PRODUCT CAME INTO CONTACT WITH A SCHOOL WORKER'S EYE AND CAUSED SWELLING AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVICIDE DISINFECTANT, MEDICAL DEVICES LRJ METREX RESEARCH CORPORATION 9-1169

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other