BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1111855 · Received August 13, 2008

    Report

    Report Number
    2084725-2008-00515
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED POSITIVE BI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SUSPECTED POSITIVE BIOLOGICAL INDICATOR (BI). THE CUSTOMER DID NOT RESPOND TO ASP'S ATTEMPT IN RETRIEVING IN MORE INFORMATION. IT IS UNKNOWN IF THERE ARE ANY PHYSICAL COMPLAINTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR BIOLOGICAL INDICATOR FRC ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD 100 S STERILIZER