BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR FREEDOM CATH

    MDR report key: 116966 · Received September 3, 1997

    Report

    Report Number
    2183558-1997-00006
    Event Type
    Injury
    Date Received
    September 3, 1997
    Report Date
    August 1, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING A PHONE CONVERSATION, THE PATIENT INDICATED HE EXPERIENCED BLISTERS ON THE INSIDE THIGH AREA WHERE CATHETER TOUCHES SKIN WHEN IN THE PRONE POSITION. PATIENT IS UNSURE WHETHER IT IS THE TUBING OR CATHETER CAUSING THE BLISTERS. HIS CARETAKER INSTRUCTED HIM TO CEASE USE OF THE CATHETER UNTIL SYMPTOMS SUBSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR FREEDOM CATH MALE EXTERNAL CATHETER EXJ MENTOR UROLOGY, INC. NA 3759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention