BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRICIDE 28

    MDR report key: 3790252 · Received May 5, 2014

    Report

    Report Number
    1722021-2014-00009
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    METREX RESEARCH
    Product Code
    MED
    PMA / PMN Number
    K931052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT NO EYE GUARD WAS USED. THE EMPLOYEE FLUSHED HER EYE FOR APPROXIMATELY FIFTEEN (15) MINUTES. THE DOCTOR TOOK THE EMPLOYEE TO AN EYE CLINIC WHERE THE EMPLOYEE WAS GIVEN EYE DROPS. THE SYMPTOMS SUBSIDED AFTER FLUSHING THE EYE AND USING EYE DROPS. TO DATE, THE EMPLOYEE IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO DHR REVIEW WAS DONE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED REPORTED THAT AN EMPLOYEE HAD EXPERIENCED A REACTION WITH SYMPTOMS OF BURNING, REDNESS AND SWELLING OF THE EYE AFTER METRICIDE 28 HAD SPLASHED INTO HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266379 METRICIDE 28 STERILANT, MEDICAL DEVICES MED METREX RESEARCH

    Patients

    Seq Age Sex Outcome Treatment
    1 2025 YR Other| R