BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA CONCENTRATE

    MDR report key: 1171517 · Received September 17, 2008

    Report

    Report Number
    2084725-2008-00580
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    JOHNSON & JOHNSON MEDICAL LTD
    Product Code
    MED
    PMA / PMN Number
    K032959
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SOLUTION SPILL.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT A CUSTOMER FOUND CIDEX OPA-C LEAK FROM THEIR ADAPTASCOPE. THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE AFFILIATE REPORTED THAT THE UNIT HAS BEEN REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA CONCENTRATE STERILANT, MEDICAL DEVICES MED JOHNSON & JOHNSON MEDICAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ADAPTASCOPE