BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT W/PROTEGEN SLING

    MDR report key: 226061 · Received June 3, 1999

    Report

    Report Number
    6000043-1999-00058
    Event Type
    Injury
    Date Received
    June 3, 1999
    Date of Event
    March 2, 1998
    Report Date
    April 15, 1999
    Manufacturer
    MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FIVE BLADDER NECK SUSPENSION PROCEDURES UTILIZING A PROTEGEN SLING WERE PERFORMED WITHOUT INCIDENT. SOMETIME POST PROCEDURE, FIVE PATIENTS RETURNED WITH SEVERE PAIN AND INFECTION. TWO OUT OF FIVE PATIENTS EXPERIENCED INABILITY TO VOID. THE SLINGS WERE REMOVED FROM ALL FIVE PATIENTS WITHOUT INCIDENT. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT ARE AVAILABLE. THE DEVICES HAVE NOT BEEN RETURNED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. DIRECTIONS FOR USE OUTLINE AS POTENTIAL COMPLICATIONS: "INFECTION IS A POTENTIAL COMPLICATION OF ANY SURGICAL PROCEDURE. ASEPTIC TECHNIQUE MUST BE ADHERED TO THROUGHOUT THE PROCEDURE. LOSS OF SUTURE SUPPORT MAY PRODUCE DEHISCENCE AT THE IMPLANT WOUND SITE...LOSS OF FIXATION AND/OR VISUALIZATION OF IMPLANTED GRAFT MATERIALS...URINARY RETENTION OR TEMPORARY OR PERMANENT LOWER URINARY TRACT OBSTRUCTION MAY RESULT FROM OVER CORRECTION INDUCED DURING A URETHRAL SLING PROCEDURE." 6000043-1999-00061, 6000043-1999-00062, 6000043-1999-00063, 6000043-1999-00064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA PERC STABILIZATION KIT W/PROTEGEN SLING PERC STABILIZATION KIT FTL MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention