BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS

    MDR report key: 5853010 · Received August 4, 2016

    Report

    Report Number
    MW5063882
    Event Type
    Other
    Date Received
    August 4, 2016
    Report Date
    July 25, 2016
    Manufacturer
    COLOPLAST CORP., / AMERICAN MEDICAL SYSTEMS INC.
    Product Code
    FAE
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THESE DEVICES HAVE CAUSED ME NOTHING BUT PAIN SINCE THEY WERE IMPLANTED. THEY HAVE NEVER HELPED ME WITH MY ERECTILE DYSFUNCTION PROBLEM AND HAVE CAUSED ME OTHER MEDICAL PROBLEMS. I HOPE THAT THESE TWO MEDICAL FORMS I AM SENDING TO YOU CAN BETTER EXPLAIN MY SITUATION. ASSESSMENT: S/P INFLATABLE PENILE PROSTHESIS INSERTION (B)(6) 2014. INCISIONS ARE HEALING WELL, PROSTHESIS TESTED BUT STILL TENDER. IRRITATION REGARDING CHAFING OF RIGHT SCROTUM AGAINST RIGHT THIGH. COMPLAINS OF LEFT LEG WEAKNESS - CAUSE UNK. PLAN: INVEST IN JOCKEY STYLE BRIEFS TO ELIMINATE FRICTION AND CHAFING. OXYCODONE FOR RESIDUAL PAIN. RETURN TO OFFICE IN 6 WEEKS TO REVIEW USE OF THE INFLATABLE PENILE PROSTHESIS INCLUDING DEFLATION. RECOMMEND THAT YOUR SPOUSE COMES TO THAT VISIT. IF SYMPTOMS WORSEN OR NEW UROLOGIC SYMPTOMS ARISE, CONTACT OFFICE FOR AN EARLIER RETURN APPOINTMENT IF INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500246 COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS FAE COLOPLAST CORP., / AMERICAN MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR