BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 837983 · Received February 22, 2007

    Report

    Report Number
    2084725-2007-00040
    Event Type
    Malfunction
    Date Received
    February 22, 2007
    Date of Event
    January 31, 2007
    Report Date
    January 31, 2007
    Manufacturer
    AVAIL MEDICAL PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K031226
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER COMPLAINED OF BURNING SENSATION AND SKIN DISCOLORATION ON THE HAND UPON REMOVAL OF A BI POUCH FROM A COMPLETED CYCLE. THE CUSTOMER STATED THE BI WAS DAMAGED IN THE POUCH. THE WORKER WAS SEEN AT EMPLOYEE HEALTH AND NO MEDICAL TREATMENT WAS RECEIVED. THE SYMPTOMS RESOLVED WITHIN ONE DAY.

    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 51 YR MODEL# 10101| STERRAD 100S STERILIZATION SYSTEM