BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISOPA SOLUTION

    MDR report key: 555977 · Received November 19, 2004

    Report

    Report Number
    2084725-2004-00084
    Event Type
    Other
    Date Received
    November 19, 2004
    Date of Event
    June 18, 2004
    Report Date
    September 14, 2004
    Manufacturer
    J & J INC
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ANAPHYLACTIC REACTION AFTER UNDERGOING A REPEAT CYSTOSCOPY PROCEDURE WITH A SCOPE THAT HAD BEEN DISINFECTED IN DISOPA SOLUTION. AFTER TEN MINUTES THE PATIENT EXPERIENCED RUBOR AND EDEMA OF THE PENILE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION DISINFECTANT MED J & J INC 17800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other GLUCONATE.| LIDOCAINE CHLORIDE AND CHLORHEXIDINE