BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA

    MDR report key: 337907 · Received June 15, 2001

    Report

    Report Number
    2084725-2001-00036
    Event Type
    Injury
    Date Received
    June 15, 2001
    Date of Event
    July 13, 2000
    Report Date
    August 16, 2000
    Manufacturer
    ADVANCED STERILIZATION PRODUCT
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY USED CIDEX OPA TO PROCESS AN OMNIPLANE TRANSESOPHAGEAL TRANSDUCER (AGILENT TECHNOLOGIES). THE TRANSESOPHAGEAL PROBE WAS UTILIZED FOR AN OPEN HEART SURGERY CASE. THE PT RECEIVED A SMALL BURN-LIKE AREA ON THE INNER/OUTER LIP. THE PT WAS SEEN AT A CARDIAC CLINIC POST-OPERATIVELY AND DIAGNOSED WITH A THROAT YEAST INFECTION. THE PT WAS AGAIN SEEN 49 DAYS AND 50 DAY LATER AND HAD A GASTROSCOPY PROCEDURE PERFORMED. THE PT WAS STILL HAVING SYMPTOMS OF A SORE AND DRY THROAT. NOTHING WAS FOUND BY THE DR WHO PERFORMED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27463 CIDEX OPA DISINFECTANT MED ADVANCED STERILIZATION PRODUCT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR OMNIPLANE TRANSESOPHAGEAL TRANSDUCER