BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 910894 · Received September 12, 2007

    Report

    Report Number
    2084725-2007-00243
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 13, 2007
    Report Date
    August 13, 2007
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO DISCUSS SOAKING TIMES AND RISING PROCEDURES FOR CIDEX ACTIVATED DIALDEHYDE (AD). DURING THE CONVERSATION IT WAS FOUND THAT THE CUSTOMER WAS SOAKING THEIR DEVICE FOR FIFTEEN MINUTES AND THEN RINSING THE DEVICE IN A KEFZOL SOLUTION THAT WOULD LATER BE USED TO IRRIGATE THE PATIENT'S MOUTH. THE CLINICAL REPRESENTATIVE INSTRUCTED THE CUSTOMER THE DEVICE SHOULD BE SOAKED IN CIDEX AD FOR 45 MINUTES AND THEN RINSED THREE TIMES IN A LARGE VOLUME OF WATER. THE CUSTOMER DENIED ANY INJURIES RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX ACTIVATED DIALDEHYDE SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 2250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR