BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSICA PERC STABILIZATION KIT W/ PROTEGEN SLING

    MDR report key: 218143 · Received April 9, 1999

    Report

    Report Number
    6000043-1999-00031
    Event Type
    Injury
    Date Received
    April 9, 1999
    Date of Event
    September 9, 1998
    Report Date
    March 12, 1999
    Manufacturer
    MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A BLADDER NECK SUSPENSION PROCEDURE UTILIZING A PROTEGEN SLING WAS PERFORMED ON 5/18/1998 WITHOUT INCIDENT. APPROX THREE MONTHS POST PROCEDURE, THE PT RETURNED WITH PAIN, URINARY RETENTION AND URETHRAL EROSION OF THE SLING MATERIAL. THE SLING WAS REMOVED WITHOUT INCIDENT. A MARTIUS FLAP PROCEDURE WAS PERFORMED TO REPAIR A FISTULA IN THE URETHRA. THERE WERE NO PT COMPLICATIONS. THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. CO'S DIRECTIONS FOR USE OUTLINE AS POTENTIAL COMPLICATIONS: "URINARY RETENTION OR TEMPORARY OR PERMANET LOWER URINARY TRACT OBSTRUCTION MAY RESULT FROM OVER CORRECTION INDUCED DURING A URETHRAL SLING PROCEDURE...LOSS OF FIXATION AND/OR VISUALIZATION OF IMPLANTED GRAFT MATERIALS. A VARIETY OF MATERIALS UTILIZED WITH SOFT TISSUE IMPLANTS HAVE BEEN KNOWN TO CAUSE CANCER AND OTHER ADVERSE REACTIONS SUCH AS TISSUE SENSITIVITY AND TISSUE EROSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSICA PERC STABILIZATION KIT W/ PROTEGEN SLING Implant BLADDER NECK SUSPENSION FHK MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention