BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING

    MDR report key: 404472 · Received July 10, 2002

    Report

    Report Number
    6000043-2002-00087
    Event Type
    Injury
    Date Received
    July 10, 2002
    Report Date
    June 12, 2002
    Manufacturer
    MICROVASIVE UROLOGY/A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FKH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SUBSEQUENT TO THE IMPLANT OF A PROTEGEN SLING, PATIENT EXPERIENCED ABDOMINAL PAIN, VAGINAL EROSION, INFECTION IN THE SLING AREA "AND/OR OTHER PHYSICAL COMPLICATIONS". IT IS NOT KNOWN WHETHER THE DEVICE REMAINS IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. COMPANY'S DIRECTIONS FOR USE OUTLINE AS POTENTIAL COMPLICATIONS: "TISSUE EROSION...INFECTION...".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other