BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 381060 · Received March 12, 2002

    Report

    Report Number
    1019632-2002-00001
    Event Type
    Other
    Date Received
    March 12, 2002
    Report Date
    March 12, 2002
    Manufacturer
    ANSELL HEALTHCARE, INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED IN 03/2002 BY EMAIL STATING THAT PATIENT USED CONDOMS WITH NONOXYNOL-9. BURNING BEGAN AS SOON AS THE CONDOM WAS PUT ON AND HAS PERSISTED FOR FIVE (5) DAYS. SECOND EMAIL RECEIVED SIX DAYS LATER STATING THAT PATIENT HAD VISITED A UROLOGIST WHO BELIEVES THIS TO BE A CHEMICAL IRRITATION URETHRITIS FROM THE CONDOMS AND SELF LIMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CONTRACEPTIVE DEVICE HIS ANSELL HEALTHCARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other