BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVICIDE

    MDR report key: 2003851 · Received February 24, 2011

    Report

    Report Number
    1722021-2011-00004
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 24, 2011
    Manufacturer
    METREX RESEARCH
    Product Code
    LRJ
    PMA / PMN Number
    951123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, RETAIN SAMPLES WERE EVALUATED YIELDING RESULTS WITHIN SPECIFICATIONS. TO DATE, THE COMPLAINANT HAS FULLY RECOVERED FROM HER REACTIONS TO THE CAVICIDE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT STATED THAT THE WORKER SOUGHT MEDICAL ATTENTION FROM A PRIVATE PHYSICIAN WHO DIAGNOSED HER SYMPTOMS AS AN ALLERGIC REACTION. THE PHYSICIAN PRESCRIBED MEDICATION TO TREAT THE ALLERGIC REACTION; HOWEVER, THE COMPLAINANT DID NOT KNOW THE NAME OF THE PRESCRIBED MEDICATION. AN EVALUATION OF THE MANUFACTURING RECORDS IS CURRENTLY IN PROCESS AND THE RESULTS OF THE INVESTIGATION, AS WELL AS FOLLOW-UP INFORMATION ON THE WORKER'S CURRENT HEALTH CONDITION, WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE USING CAVICIDE TO CLEAN THE OFFICE, A WORKER EXPERIENCED BURNING, ITCHING AND SWELLING EYES WHICH REQUIRED A PRESCRIPTION MEDICATION FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVICIDE DISINFECTANT, MEDICAL DEVICES (LRJ) LRJ METREX RESEARCH 10-2301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other