BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLUME ENDOPROSTHESIS

    MDR report key: 3017350 · Received March 15, 2013

    Report

    Report Number
    2183959-2013-00755
    Event Type
    Injury
    Date Received
    March 15, 2013
    Report Date
    March 4, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UROLOGY ANNALS, UROL ANN, 2012 SEP-DEC; 4(3): 191-194, FRANCISCO BOTHELHO, ANIL A. THOMAS, RANKO MIOCINOVIC, AND KENNETH W. ANEMEIER, DEPT OF UROLOGY, S. JOAO HOSPITAL, PORTO, PORTUGAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE WITH A HISTORY OF NEUROGENIC BLADDER HAD PRESENTING SYMPTOMS OF "RECURRENT URINARY TRACT INFECTIONS, OBSTRUCTIVE VOIDING SYMPTOMS, AND AN INABILITY TO PERFORM SELF-CATHETERIZATION." IT WAS ALSO REPORTED THAT THE PT HAD PREVIOUSLY SUSTAINED A T6 SPINAL CORD INJURY AND HAD A SPHINCTERECTOMY AND UROLUME (URETHRAL STENT) PLACED 10 YEARS AGO TO TREAT DETRUSOR-SPHINCTER DYSSYNERGIA AND BLADDER OUTLET OBSTRUCTION. THE PHYSICIAN FOUND A "CALCIFIED URETHRAL STENT" ON A PLAIN-KIDNEY-URETER-BLADDER RADIOGRAPH. A "FLEXIBLE URETHROSCOPY CONFIRMED THE PRESENCE OF SEVERELY ENCRUSTED STENT AT THE BLADDER NECK, WHICH ALMOST COMPLETELY OBSTRUCTED THE URETHRAL LUMEN." THE PT UNDERWENT LASER FRAGMENTATION AND EXTRACTION OF THE CALCIFIED STENT. UPON COMPLETION OF THE PROCEDURE, THE BLADDER OUTLET WAS NOTED TO BE "PATENT AND WITHOUT ANY EVIDENCE OF RESIDUAL STENT FRAGMENTS." IT WAS ALSO REPORTED THAT THE PT'S "PROSTATIC URETHRA REMAINED AT 7 MONTHS FOLLOW-UP AND THE PT RESUMED INTERMITTENT SELF-CATHETERIZATION WITHOUT DIFFICULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110564 UROLUME ENDOPROSTHESIS ENDOURETHRAL PROSTHESIS MES AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R