BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXICIDE PLUS 3.4% GLUTARALDEHYDE

    MDR report key: 3112550 · Received May 14, 2013

    Report

    Report Number
    1722021-2013-00012
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    METREX RESEARCH
    Product Code
    MED
    PMA / PMN Number
    K931592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EMPLOYEE IS DOING FINE. THE EMPLOYEE VISITED THE EMERGENCY ROOM WHERE THEY FLUSHED HER EYE WITH A SALINE SOLUTION. THE EMPLOYEE VISITED HER OPTOMETRIST FOR A FOLLOW UP; THE DOCTOR SAID EVERYTHING WAS FINE. THE DOCTOR OFFICE REPORTED THAT THE EMPLOYEE WAS USING THE PRODUCT WITHOUT WEARING EYE PROTECTION; THE MAXICIDE PLUS LABEL STATES THAT EYE PROTECTION IS REQUIRED WHEN USING THE PRODUCT. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. THERE WERE NO EVIDENCE OF PRODUCT MALFUNCTION; THEREFORE, NO FURTHER EVALUATIONS ARE NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT ONE (1) EMPLOYEE HAD EXPERIENCED A REACTION OF BURNING AND EYE IRRITATION AFTER MAXICIDE HAD SPLASHED INTO HER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213251 MAXICIDE PLUS 3.4% GLUTARALDEHYDE STERILANT, MEDICAL DEVICES MED METREX RESEARCH 12-3118

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other| R