BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1051610 · Received May 22, 2008

    Report

    Report Number
    2084725-2008-00203
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A CUSTOMER REPORTED AN EMPLOYEE EXPERIENCED REDNESS AND RASH WHEN USING CIDEX PLUS WITHOUT GLOVES. THE EMPLOYEE SAW A DOCTOR AND WAS TREATED WITH AN UNK TREATMENT. THE CUSTOMER HAS DISCONTINUED USING THE PRODUCT. THE INSTRUCTIONS FOR USE AND THE MATERIAL SAFETY DATA SHEET WERE REVIEWED WITH THE DISTRIBUTOR TO NOTE THAT GLOVES ARE REQUIRED WHILE USING THE PRODUCT.

    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