BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBER FREEDOM CATH

    MDR report key: 116944 · Received September 3, 1997

    Report

    Report Number
    2183558-1997-00005
    Event Type
    Injury
    Date Received
    September 3, 1997
    Report Date
    July 31, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    EXJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A PHONE CONVERSATION, THE ATTENDING NURSE INDICATED THE PATIENT EXPERIENCED BLISTERING AND REACTION TO THE CATHETER. SHE WAS UNSURE IF THIS IS A LATEX REACTION...BUT REPORTED SWELLING AND BLISTERING AT THE BASE OR NEAR THE ADHESION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBER FREEDOM CATH MALE EXTERNAL CATHETER EXJ MENTOR UROLOGY, INC. NA 4111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention