BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1283361 · Received January 8, 2009

    Report

    Report Number
    2084725-2009-00013
    Event Type
    Injury
    Date Received
    January 8, 2009
    Date of Event
    December 17, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - INHALATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED TO HAVE EXPERIENCED HUMAN REACTIONS FROM USING CIDEX PLUS. THE CUSTOMER EXPERIENCED A BURNING COUGH, BURNING EYES, AND A HEADACHE. THE CUSTOMER HAS HAD ASTHMA AND BRONCHITIS FOR SOME TIME AND HAD BEEN PRESCRIBED MEDICATION. THE CUSTOMER DID SEEK ADDITIONAL MEDICAL ATTENTION FOR THE SYMPTOMS. THE CUSTOMER DID NOT USE ANY PERSONAL PROTECTIVE EQUIPMENT. THE CUSTOMER WAS RINSING UNDER WATER AND NOT BY IMMERSION. THE CUSTOMER WAS ADVISED TO CHECK THE VENTILATION OF THE AREA TO MAKE SURE IT IS AT LEAST A MINIMUM OF 10 EXCHANGES PER HOUR. THE AIR EXCHANGES HAVE NOT BEEN MEASURED AND THE ROOM IS NOT WELL VENTILATED. HE REPORTS THAT HE IS CURRENTLY UNDER THE CARE OF A PULMONOLOGIST. THE CUSTOMER LATER STATED HE DOES NOT THINK IT WAS CIDEX PLUS THAT CAUSED THE ASTHMA. HE ALSO STATED THAT HE STILL HAS THE SYMPTOMS. CIDEX PLUS HAS NOT BEEN USED FOR THREE WEEKS. THE CUSTOMER IS STILL ON THE SAME MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR