BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1230270 · Received November 13, 2008

    Report

    Report Number
    2084725-2008-00758
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    JOHNSON & JOHNSON MEDICAL LTD.
    Product Code
    MED
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THEY HAD A PT WHO EXPERIENCED STAINING IN THE MOUTH AND SWELLING OF THE TONGUE AFTER A PROBE WAS PROCESSED IN CIDEX OPA. THE CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPTS IN RETRIEVING MORE 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