BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 709587 · Received May 4, 2006

    Report

    Report Number
    2084725-2006-00052
    Event Type
    Malfunction
    Date Received
    May 4, 2006
    Date of Event
    April 19, 2006
    Report Date
    April 19, 2006
    Manufacturer
    AVAIL MEDICAL PRODUCTS
    Product Code
    FRC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER EXPERIENCED A BURNING SENSATION WITH WHITENING OF THE SKIN TO HER FINGERTIPS AFTER HANDLING A CYCLESURE BIOLOGICAL INDICATOR(BI). THE AMPOULE HAD CRACKED DURING THE STERRAD CYCLE. THE WORKER IMMEDIATELY RINSED HWE HANDS IN WATER AND DID NOT SEEK MEDICAL ATTENTION. THE WORKER'S SYMPTOMS RESOLVED WITHIN ONE HOUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN