BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1008119 · Received March 6, 2008

    Report

    Report Number
    2084725-2008-00048
    Event Type
    Injury
    Date Received
    March 6, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A "STRONG ALLERGIC REACTION" WHEN WORKING IN A ROOM WITH CIDEX OPA. THE CUSTOMER REPORTED, "DIFFICULTY BREATHING, HIVES AND SWELLING OF THE MOUTH, THROAT, AND TONGUE" THAT WENT OCCURRED "OFF AND ON FOR ABOUT A MONTH". THE CUSTOMER SAW AN ENT DR WHO ORDERED A CT SCAN, WHICH REPORTEDLY SHOWED "LYMPH NODE ENLARGEMENT". THE DR PRESCRIBED THE CUSTOMER AN "EPI-INHALER, ANTIBIOTICS, AND STEROIDS". THE CUSTOMER REPORTED THAT THE AIR EXCHANGES IN THE ROOM WHERE THE CIDEX OPA IS USED HAVE NEVER BEEN MEASURED. ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER TO FIND OUT HOW SHE RECOVERED, THE CUSTOMER WAS NOT AVAILABLE.

    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 50 YR