BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1040865 · Received May 9, 2008

    Report

    Report Number
    2084725-2008-00158
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SUSPECTED POSITIVE BIOLOGICAL INDICATOR (BI). UPON INITIAL REPORT, THE CUSTOMER STATED THAT THE CUSTOMER RECALLED MOST OF THE ITEMS IN THE LOAD MEANING THAT NOT ALL ITEMS WERE RECALLED. ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER REGARDING WHETHER OR NOT ALL ITEMS WERE RECALLED AND THE CUSTOMER WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL FRC AVAIL MEDICAL PRODUCTS 14324 29971Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG #10101| STERRAD 100S STERILIZATION SYSTEM