BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 1032862 · Received April 22, 2008

    Report

    Report Number
    9615742-2008-00014
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 16, 2008
    Manufacturer
    TREVOUS - USS
    Product Code
    FTL
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 04/22/2008.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED THAT THE PT EXPERIENCED HEMATURIA BEGINNING IN 2008 FOLLOWING A URETHRAL SUPPORT PROCEDURE IN 2004. VIA CYSTOSCOPY, THE DOCTOR OBSERVED EROSION OF A SMALL PIECE OF MATERIAL AT THE MID-URETHRA ON THE PT'S RIGHT SIDE. IN 2008, THE DOCTOR UNSUCCESSFULLY ATTEMPTED TO CUT AND REMOVE THE PIECE WITH ENDOSCOPIC SCISSORS. HE ALSO UNSUCCESSFULLY ATTEMPTED TO REMOVE THE PIECE WITH A HOLMIUM LASER AT 20 WATTS. IF A TRANSURETHRAL ATTEMPT FAILS, THE DOCTOR WILL REMOVE THE PIECE TRANSVAGINALLY. THE PT WAS GIVEN KEFLEX POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP KIT X1 SURGICAL MESH FTL TREVOUS - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention