BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT W/PROTEGEN SLING

    MDR report key: 167686 · Received May 18, 1998

    Report

    Report Number
    6000043-1998-00057
    Event Type
    Injury
    Date Received
    May 18, 1998
    Date of Event
    February 16, 1998
    Report Date
    April 20, 1998
    Manufacturer
    MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F11. DATE MFR INITIALLY FORWARDED REPORT TO FDA. H2. CORRECTION: IT WAS FOUND THAT THIS MDR IS A DUPLICATE OF 6000043-1998-00024 AND SHOULD BE VOIDED OR MADE NULL. REPORT 6000043-1998-00057 CONTAINS THE COMPLETE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED A BLADDER NECK SUSPENSION PROCEDURE UTILIZING PROTEGEN SLING WAS INITIALLY PERFORMED WITHOUT INCIDENT ON 2/16/98. APPROX FIVE WEEKS POST PROCEDURE, THE PT RETURNED WITH BLOODY DISCHARGE AND URETHRAL EROSION OF THE SLING MATERIAL WAS NOTED. THE SLING MATERIAL WAS REMOVED ON 4/14/98 WITHOUT INCIDENT AND THE PT UNDERWENT TREATMENT WITH ANITBIOTICS AND PREMARIN CREAM. NO FURTHER INFO REGARDING THE CIRCUMSTANCES SURROUNDING THE EVENT ARE AVAILABLE. THE DEVICE HAS BEEN DESTROYED BY THE UF. THEREFORE, NO FAILURE ANALYSIS WILL BE PERFORMED. F/U INDICATED THE PT WAS CLEANSING WITH A BETADYNE DOUCHE FOR APPROX ONE WEEK SOMETIME PRIOR TO RETURNING FOR REASSESSMENT WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE OUTLINE AS POTENTIAL COMPLICATIONS: "THE PT MUST BE ADVISED TO AVOID PHYSICAL STRAIN, SUCH AS HEAVY LIFTING FOR TWO TO THREE POST OP AND PHYSICAL VAGINAL ACTIVITY (SEXUAL INTERCOURSE, DOUCHING, TAMPON USAGE, ETC.) FOR SIX TO EIGHT WEEKS POST OPERATIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA PERC STABILIZATION KIT W/PROTEGEN SLING Implant PERC STABILIZATION KIT FTL MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP. NA 047108

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention