BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1052645 · Received May 23, 2008

    Report

    Report Number
    2084725-2008-00192
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 23, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EMPLOYEES WHO COMPLAINED OF PHYSICAL SYMPTOMS WHILE WORKING WITH CIDEX OPA. THE CUSTOMER USES THE SOLUTION TO PROCESS VAGINAL PROBES. THE CUSTOMER REPORTS HAVING THREE AIR EXCHANGES AN HOUR IN THE PROCESSING ROOM SO THEY USE A GUS SYSTEM. THE EMPLOYEE REPORTED SKIN RASH AND ITCHING, AND HOARSENESS. THE EMPLOYEE SAW A DERMATOLOGIST AND HAD LAB TESTS AND A SKIN BIOPSY. THE CUSTOMER ALSO REPORTED THAT THERE WAS CONSTRUCTION OCCURRING ELSEWHERE IN THE BUILDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 20390 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR