BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VESSICA PERC STABILIZATION KIT W/PROTEGEN

    MDR report key: 275085 · Received April 26, 2000

    Report

    Report Number
    6000043-2000-00011
    Event Type
    Injury
    Date Received
    April 26, 2000
    Date of Event
    October 16, 1997
    Report Date
    April 26, 2000
    Manufacturer
    MICROVASIVE UROLOGY/A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PROTEGEN SLING PLACEMENT IN 1997, THE PT EXPERIENCED VAGINAL DISCHARGE, BLEEDING, PAIN, TENDERNESS AND DYSPAREUNIA. IT WAS REPORTED ON OR BEFORE 8/27/1997 ANOTHER PHYSICIAN BECAME AWARE OF PALPABLE AND/OR EXPOSED SUTURES IN THE AREA OF THE ATTACHMENT OF THE PROTEGEN SLING. ON OR ABOUT 10/13/1997 THE PT WAS EXAMINED BY ANOTHER UROLOGIST WHO NOTED EROSION OF THE SLING MATERIAL THROUGH THE VAGINAL WALL. IN 1997, THAT PT UNDERWENT CYSTOURETHROSCOPY WITH REMOVAL OF THE ERODING PROTEGEN SLING WAS NOT ADHERENT TO THE SURROUNDING TISSUE AT THE TIME OF REMOVAL; RETAINED SUTURES WERE NOTED IN THE PT'S BLADDER. NO PRODUCT WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK VESSICA PERC STABILIZATION KIT W/PROTEGEN PERC STABILIZATION KIT FHK MICROVASIVE UROLOGY/A DIV OF BOSTON SCIENTIFIC CORP. NA 663154

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention