BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1003400 · Received February 21, 2008

    Report

    Report Number
    2084725-2008-00032
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    AVAIL MEDICAL PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WITH A SUSPECTED POSITIVE BIOLOGICAL INDICATOR (BI). THE CUSTOMER DID NOT RECALL ALL ITEMS FROM THE LOAD. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING POTENTIAL PATIENT INJURY RELATED TO THE UNRECALLED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL FRC AVAIL MEDICAL PRODUCTS 14324 25771Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK