BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR ADVANTAGE MALE EXTERNAL CATHETER

    MDR report key: 118533 · Received September 10, 1997

    Report

    Report Number
    2183558-1997-00009
    Event Type
    Injury
    Date Received
    September 10, 1997
    Report Date
    August 13, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    EXJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A LETTER FROM THE ATTENDING PHYSICIAN IT WAS INDICATED THAT THIS PT EXPERIENCED AN "IRRITANT CONTACT VS. AN ALLERGIC CONTACT DERMATITIS JUST UNDER THE CONDOM SITE ON THE PENIS." IN FURTHER CONVERSATION WITH THE PHYSICIAN'S STAFF IT WAS INDICATED THE PT HAS A "WEEPY" RASH THAT COVERS THE ENTIRE SURFACE OF THE PENIS AND THAT THE PHYSICIAN HAD PROVIDED SPECIAL INSTRUCTIONS TO THE PT TO CHANGE THE CATHETER 3-4 TIMES A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR ADVANTAGE MALE EXTERNAL CATHETER SILICONE MALE EXTERNAL CATHETER EXJ MENTOR UROLOGY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention