BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA

    MDR report key: 337926 · Received June 15, 2001

    Report

    Report Number
    2084725-2001-00041
    Event Type
    Injury
    Date Received
    June 15, 2001
    Report Date
    August 18, 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

    AN OMNIPLANE TRANSESOPHAGEAL TRANSDUCER (AGILENT TECHNOLOGIES) WAS PROCESSED USING CIDEX OPA. FOLLOWING THE PROCESSING, THE TRANSDUCER WAS USED ON THE PT DURING OPEN HEART SURGERY. FOLLOWING SURGERY, THE PT DEVELOPED A SMALL BLISTER ON THE UPPER LIP. THE BLISTER RESOLVED WITHOUT RESIDUAL AT THE TIME OF DISCHARGE IN 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27709 CIDEX OPA DISINFECTANT MED ADVANCED STERILIZATION PRODUCT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR OMNIPLANE TRANSESOPHEAGEAL TRANSDUCER (AGILENT)