BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE

    MDR report key: 600004 · Received May 5, 2005

    Report

    Report Number
    2183911-2005-00002
    Event Type
    Other
    Date Received
    May 5, 2005
    Date of Event
    September 10, 2004
    Report Date
    May 3, 2005
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005 CLARUS MEDICAL WAS NOTIFIED THA A PT MAY HAVE BEEN INJURED DURING A PROCEDURE INVOLVING A LASE 1100-002. THE PT APPARENTLY HAS SOME ELEMENTS OF CAUDA EQUINE SYNDROME WHICH ARE RESOLVING OVER TIME. NO ALLEGATION THAT THE LASE 1100-002 DEVICE FAILED IN ANY WAY HAS BEEN MADE. THE PT HAD TROUBLE VOIDING "URINE" AND HAS LOST CONTROL OF PTS BOWELS. THIS PROBLEM DID NOT REOCCUR. THE PT COMPLAINED OF ERRECTION PROBLEMS AND EJACULATION PROBLEMS. THE PT IS BEING MONITORED BY THE PHYSICIAN THAT DID THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASE * GEX CLARUS MEDICAL, LLC. 1100-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other