BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1191216 · Received September 26, 2008

    Report

    Report Number
    2084725-2008-00592
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO IMPACT OR CONSEQUENCES TO PT, OTHER, SUSPECTED POSITIVE BI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SUSPECTED POSITIVE BIOLOGICAL INDICATOR (BI), THE CUSTOMER REPORTED THAT LOAD WAS PARTIALLY RECALLED. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS RELATED TO THE UNRECALLED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR BIOLOGICAL INDICATOR FRC ADVANCED STERILIZATION PRODUCTS NA 17681Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA STERRAD 100NX 1-DR