BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1191169 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00599
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    JOHNSON & JOHNSON MEDICAL LTD.
    Product Code
    MED
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER: BURNING NOSTRILS) - (OTHER, INHALATION).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WORKS IN A ROOM WITH NO WINDOW OR VENTILATION FOR UP TO 13 HOURS A DAY. THE FACILITY IS USING CIDEX OPA IN AN AER. SHE HAS EXPERIENCED BURNING OF THE INNER NOSTRILS AND HAS LESIONS INSIDE HER NOSE. THERE WERE NO OTHER PRODUCTS USED IN THIS ROOM OTHER THAN AN UNK ENZYMATIC DETERGENT, HOWEVER, THE CUSTOMER FEELS VERY STRONGLY THAT THE CIDEX OPA IS CAUSING THE SYMPTOMS. THE CALLER HAS SEEN AN ENT DR AND THE DR SAYS HE BELIEVES IT IS A SINUS ISSUE AND DOES NOT FEEL A BIOPSY OR ANY OTHER FURTHER TREATMENT IS REQUIRED. THE DR DID NOT PRESCRIBE ANY MEDICATION. ASP CUSTOMER CARE REVIEWED MSDS WITH THE CUSTOMER. THE CUSTOMER DID NOT WANT TO PROVIDE HER LAST NAME, NAME AND NUMBER OF THE FACILITY. THERE IS NO PT OUTCOME INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED JOHNSON & JOHNSON MEDICAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK