BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIDEX 14

    MDR report key: 410539 · Received August 12, 2002

    Report

    Report Number
    2084725-2002-00032
    Event Type
    Other
    Date Received
    August 12, 2002
    Report Date
    July 31, 2002
    Manufacturer
    J & J PRODUCTS PROFISSIONALS, RODOVIA PRESIDENTE DUTRA
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PT'S HAD DEVELOPED FEVERS AFTER OPERATIONS. THE INSTRUMENTS USED IN THE LAPAROSCOPY PROCEDURES WERE DISINFECTED WITH CIDEX. IT WAS STATED THAT THE PRODUCT HAD BEEN IN USE FOR 21 DAYS. THIS PRODUCT HAS A MAXIMUM REUSE PERIOD OF 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX 14 LIQUID CHEMICAL STERILANT/DISINFECTANT FLE J & J PRODUCTS PROFISSIONALS, RODOVIA PRESIDENTE DUTRA NA U05-058R

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other