BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING

    MDR report key: 507468 · Received January 21, 2004

    Report

    Report Number
    6000043-2004-00002
    Event Type
    Injury
    Date Received
    January 21, 2004
    Report Date
    October 28, 2003
    Manufacturer
    MICROVASIVE UROLOGY/BOSTON SCIENTIFIC
    Product Code
    FHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO THE IMPLANT OF A PROTEGEN SLING FOR TREATMENT IN 97, THE PT EXPERIENCED ABDOMINAL PAIN, CONTINUED INCONTINENCE, VAGINAL DISCHARGE, NEUROLOGICAL AND GASTROINTESTINAL COMPLAINTS AND URINARY TRACT INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING PERC STABILIZATION KIT FHK MICROVASIVE UROLOGY/BOSTON SCIENTIFIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention