BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1040856 · Received May 9, 2008

    Report

    Report Number
    2084725-2008-00166
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPILL OF CIDEX PLUS. THE CUSTOMER REPORTED THAT THEY WERE KEEPING THE BOTTLE OF SOLUTION ON THE FLOOR WITH AN INSTRUMENT IN IT AND THAT IT WAS KICKED OVER. THE EMPLOYEE REPORTED THAT THE SOLUTION IRRITATED HER THROAT. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT FOR THE SYMPTOM. THE CUSTOMER WAS INSTRUCTED TO USE APPROPRIATE TRAYS FOR SOAKING INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 2785 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK