BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1230831 · Received November 6, 2008

    Report

    Report Number
    2084725-2008-00726
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INHALATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CIDEX OPA SOAKING STATION IS USED IN THE DOCTOR'S OFFICE. THE CUSTOMER ALLEGED THAT THE DOCTOR EXPERIENCED NASAL SYMPTOMS ("SINUS PRESSURE AND STUFFINESS") FOR THREE DAYS SINCE HE MOVED TO THE OFFICE. THE CIDEX OPA IS USED MANUALLY IN AN UPRIGHT SOAKING STATION. THE CUSTOMER DID NOT PROVIDE THEIR OFFICE VENTILATION INFO. THE ASP CUSTOMER CARE REVIEWED AND FIRST AID INFO FROM MSDS WITH CUSTOMER. THE ASP CUSTOMER CARE ALSO REVIEWED AND FAXED THE CIDEX OPA VAPOR CUSTOMER LETTER.

    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